MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM STM STD 36+12L 13X18; HIP FEMORAL STEM/SLEEVE

Catalog Number 563618

Device Problems Disassembly (1168); Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923); Osseointegration Problem (3003)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Injury (2348); Ambulation Difficulties (2544); Inadequate Osseointegration (2646); No Information (3190); Unspecified Musculoskeletal problem (4535); Physical Asymmetry (4573); Swelling/ Edema (4577)

Event Date 04/27/2016

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

Patient was revised due to dislocation, and head disassociating from stem.

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Manufacturing records have been reviewed for all three product / lot combinations associated with this report.No related deviations or anomalies were identified.Corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: added: description of event or problem and evaluation codes (patient).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Litigation records received.Litigation alleges that the surgeon failed to determine that the products implanted on the patient did not correctly match nor fit with each other which resulted to the disassociation of the implants.The patient experienced pain, suffering, injury and walking difficulty.Doi: (b)(6) 2016.Dor: (b)(6) 2016.Left hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.The device manufacturing record (dhr) has been reviewed.No related anomalies or deviations identified.The root cause is attributed to use error.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Patient had been reported some clicking in the hip prior to the revision.Left hip is shortened and painful on range of motion and palpation and have some swelling.X-ray showed that the prosthesis had broken.Revision notes stated that the acetabular cup had shifted with anterior displacement of the stem.Cup, head, liner, and stem were removed.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Medical records reviewed: on (b)(6) 2016 the patient had a left total hip arthroplasty and a right total knee arthroplasty to address osteoarthritis.Left hip: depuy pinnacle cup along with srom were used during this procedure.Right knee arthroplasty: competitor products, including competitor cement were used during this procedure were implanted during this procedure.On (b)(6) 2016 patient had a revision left hip to address left hip implant dissociation, and clicking in hip.There was a disassociation between the femoral head component and the stem.During the procedure the surgeon noted the acetabular cup had shifted with the anterior displacement of the stem.The stem was noted to be well fixed.The surgeon reported that the acetabulum appeared to have shifted slightly and the assumption was made that there was increased anteversion that may have contributed to the dissociation.The cup was revised, along with the liner, head, and stem.Two screws were used to fix cup.Depuy components were implanted during this procedure.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary the device associated with this report was not returned to depuy synthes for evaluation.Review of the x-ray evidence was able to confirm the complaint.It was observed that a disassociation event occurred between the femoral head and stem.Additionally, device has been reported to be used incorrectly since the implant match/fit was not verified.A 12/14 tapered femoral head was used on a 11/13 tapered femoral stem.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records (mre) was not performed.

Manufacturer Narrative

Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5, h6 (clinical and medical device problem code) if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Medical records were received: on (b)(6) 2023, the patient went for a clinic visit and had an initial complaint of pain all over his hips.Symptoms began after the surgery.Pain is described as aching and constant.Rom grossly intact with pain.Pain was reported over the lateral hip extending down over the anterior/lateral thigh.X-ray findings lucency noted suggesting loosening of the femoral stem with a bony pedestal noted at the distal end.On (b)(6) 2023, the patient underwent a left hip revision.Intraoperative findings included that the srom sleeve and stem were grossly loose at the bone to implant interface.Osteotomes and an oscillating saw were created to clear away extra bone in order to release the stem and sleeve.Subsidence was also identified which also caused a loss of leg length.The patient was converted to a dual mobility system but no allegations were noted against the original liner/head.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: according to the information received, ¿complaint description: patient was revised due to dislocation, and head disassociating from stem¿ the product was not returned to depuy synthes, however photos were provided for review.See attachments "(b)(4)_x-ray_images-received (b)(6) 2022" and "(b)(4) x-ray films ad (b)(6) 2022 (1)-(4)".Review of the photographic evidence revealed that the acetabular head had disassociated from the femoral stem, most likely due to the reported incorrect use of the implants since the implant fit was not verified and a 12/14 tapered femoral head was used on a 11/13 tapered femoral stem.Additionally, signs of what appears to be radiolucency was observed between the distal portion of the stem and the femur.However, based on the available information the allegation of loosening cannot be confirmed.The overall complaint was partially confirmed as the observed condition of the srom stm std 36+12l 13x18 would contribute to the complained device issue.Potential cause can be attributed to unintended use error.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records (mre) was not performed.

• Brand Name: SROM STM STD 36+12L 13X18
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 5667936
• MDR Text Key: 45568739
• Report Number: 1818910-2016-19686
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK851422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 563618
• Device Lot Number: 8126323
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2016
• Initial Date FDA Received: 05/19/2016
• Supplement Dates Manufacturer Received: Not provided; 12/12/2018; 07/10/2020; 02/17/2021; 05/03/2021; 07/07/2021; 08/11/2022; 11/30/2022; 02/27/2023; 03/16/2023; 12/21/2023; 05/21/2024
• Supplement Dates FDA Received: 08/18/2016; 12/19/2018; 07/14/2020; 03/03/2021; 05/28/2021; 07/16/2021; 08/24/2022; 12/12/2022; 03/03/2023; 03/17/2023; 01/03/2024; 05/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ALTRX NEUT 36IDX64OD; DELTA CER HEAD 12/14 36MM +12; PINN SECTOR W/GRIPTION 64MM
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 108 KG