MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DLT TS CER HD 12/14 36MM +8.5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Model Number 1365-36-730

Device Problems Naturally Worn (2988); Noise, Audible (3273)

Patient Problems Adhesion(s) (1695); Fatigue (1849); Foreign Body Reaction (1868); Pain (1994); Weakness (2145); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 08/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the primary tha was on (b)(6) 2016 by dr.At (b)(6) health.Revision tha was on (b)(6) 2016 by dr.At (b)(6) health (head and liner revised, acetabular screw removed).The patient came to the orthopedic urgent care located in (b)(6).Clinic complaining of pain.X-rays revealed what appeared to be a failure at the interface of the acetabular shell and poly liner.If accurate, this would be the second such dissociation for this patient since the original surgery in 2016.The poly and head were revised in 2018 for the same indication.The patient is adamant that this is a failure on the part of depuy and has indicated that she will be seeking legal remedy against depuy.Revision surgery is indicated and will be performed by dr.(date to be determined).The patient has indicated that her preference would be that no depuy products are to be used in the revision.Please bring this to the attention of legal.

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).Investigation summary : no device associated with this report was received for examination.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.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.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary; the device associated with this report was not returned to depuy synthes for evaluation.An x-ray review was performed and confirmed the reported allegation.The investigation found the head and cup component making direct contact, therefore it is reasonable to confirm audible sound and wear on the head.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.

Event Description

Medical records were received and stated the following: on (b)(6) 2019, the patient had a left total hip revision to address the recurrent failure of the left hip with recurrent dissociation of the acetabular polyethylene liner.Preoperative radiographs revealed an asymmetric position of the femoral head within the acetabulum consistent with dissociation of the poly liner.Prior to surgery, the patient experienced pain, limping, clicking, and weakness in the left hip.During the procedure, the surgeon observed a small amount of black metallic staining in the synovium of the soft tissue, and the liner had disassociated from the cup.The ceramic femoral head showed evidence of significant wear and scratching from the acetabular component.The acetabular cup, liner, and femoral head were revised.Competitor acetabular components along with depuy ceramic femoral head were implanted during this procedure.

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.

• Brand Name: DLT TS CER HD 12/14 36MM +8.5
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9953912
• MDR Text Key: 187699367
• Report Number: 1818910-2020-10647
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033677
• UDI-Public: 10603295033677
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071830
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/01/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 1365-36-730
• Device Catalogue Number: 136536730
• Device Lot Number: 8562734
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/30/2020
• Initial Date FDA Received: 04/13/2020
• Supplement Dates Manufacturer Received: 07/20/2021; 02/09/2023; 03/30/2023; 04/25/2023
• Supplement Dates FDA Received: 07/28/2021; 02/10/2023; 04/19/2023; 04/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2017
• 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 +4 10D 36IDX54OD; CORAIL2 LAT COXA VARA SIZE 12; DLT TS CER HD 12/14 36MM +8.5; PINN CAN BONE SCREW 6.5MMX45MM; PINN SECTOR W/GRIPTION 54MM; UNKNOWN HIP IMPLANT (SCREW)
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female