MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DLT TS CER HD 12/14 28MM +5.0; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Catalog Number 136528720

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Joint Dislocation (2374)

Event Date 02/27/2024

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, depuy synthes, 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 was revised due to dislocation and pain.When the surgeon took the patient to surgery he went in and found a dislocated competitor cup and depuy reclaim stem.The surgeon removed the femoral head off of the stem to have better access at the acetabular component.The competitor cup was removed and a pinnacle revision dpx cup was implanted.Doctor choose to use a constrained insert.A sz68 dpx cup was chosen, because a 68mm rev cup was chosen a 40x62 constrained insert was then inserted.Because the new insert was implanted, a 40+1.5 ts ceramic head was chosen.The patient was closed in the usual fashion.Doi: (b)(6) 2023 dor: (b)(6) 2024 affected side: right hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.

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

Additional information was received and stated that the reçlaim stem in place was not the issue of concern.The reclaim stem in place was solidly fixed and well positioned, thus the femoral stem was retained.Only the femoral head was exchanged for a different size and length.

• Brand Name: DLT TS CER HD 12/14 28MM +5.0
• 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): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18858083
• MDR Text Key: 337130731
• Report Number: 1818910-2024-05366
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295033318
• UDI-Public: 10603295033318
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2024

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 Catalogue Number: 136528720
• Device Lot Number: 4114035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: 03/07/2024; 03/26/2024
• Supplement Dates FDA Received: 03/13/2024; 03/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2023
• 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: STRYKER CUP; UNK HIP FEMORAL STEM RECLAIM DISTAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female