MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 64MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-32-064
Medical Device Problem Codes	Use of Device Problem (1670); Noise, Audible (3273); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Ambulation or Postural Difficulties (2544); Physical Asymmetry (4573); Swelling/ Edema (4577)
Date of Event	04/27/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Occupation: initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Complaint description: patient was revised due to dislocation, and head disassociating from stem.On (b)(6) 2021: 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.
Additional 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.
Additional 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 or Problem 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.
Additional 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned to depuy synthes for evaluation.Based on the provided x-ray evidence, no clear signs of device mis-position or movement were identified.Nothing that would indicate audible sound was observed on the evidence.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 evaluation (mre) was not performed.
Additional 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 or Problem 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.

• Brand Name: PINN SECTOR W/GRIPTION 64MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 11844633
• Report Number: 1818910-2021-10611
• Device Sequence Number: 17309024
• Product Code: KWA
• UDI-Device Identifier: 10603295010364
• UDI-Public: 10603295010364
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K093646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1217-32-064
• Device Catalogue Number: 121732064
• Device Lot Number: 528882
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 07/07/2021; 08/11/2022; 11/30/2022; 03/16/2023; 12/21/2023
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 07/16/2021; 08/24/2022; 12/12/2022; 03/17/2023; 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALTRX NEUT 36IDX64OD; DELTA CER HEAD 12/14 36MM +12; PINN SECTOR W/GRIPTION 64MM; SROM STM STD 36+12L 13X18
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 108 KG