MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX LIP LNR 32IDX52OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1221-32-252
Medical Device Problem Codes	Difficult to Insert (1316); Wrong Label (4073)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/31/2023
Type of Reportable Event	Serious Injury
Additional 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.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
It was reported that a primary, total right hip replacement was performed using the corail and pinnacle products.In this case, the size of acetabular liner chosen was a lipped 32mm id 52mm od liner.The implants were collected by a theatre support worker from a storeroom where all implants are kept.The label on the box, as well as the stickers from the box both had the following description: pinnacle altrx polyethylne, acetabular liner, lipped 32mm id 52mm od, ref: 1221-32-252, lot:m2706y.The size of the liner was confirmed by surgeon prior to opening of all implants.The liner was opened, placed in the acetabular cup, and the surgery proceeded.The femoral head used was a biolox delta ceramic femoral head +1 32mm dia 12/14 taper, which is supposed to correspond with the acetabular liner.The femoral head was inserted into the liner.No dislocation occurred.Following the procedure, post-operative x-rays were taken.The x-rays displayed that the femoral head did not fit the acetabular liner correctly and did not correspond with the acetabular liner.As a result, a revision surgery was performed on the (b)(6) 2023 at the hospital.The acetabular liner remained in the patient, and the +1 32mm dia 12/14 taper femoral head was replaced with a 28mm dia 12/14 taper femoral head.The new femoral head fit into the acetabular liner during the revision surgery, as well as when examined on the post operative x-rays.This suggests that the acetabular liner labelled as lipped 32mm id 52mm od liner was in fact a lipped 28mm id 52mm od liner, and was either labelled incorrectly, or had been placed in the incorrect box.
Additional 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: a manufacturing record evaluation (nc search) was performed, for the finished device product code:122132252, lot code#: m2706y.And no non-conformances / manufacturing irregularities were identified.

• Brand Name: ALTRX LIP LNR 32IDX52OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17181063
• Report Number: 1818910-2023-12731
• Device Sequence Number: 6391976
• Product Code: LPH
• UDI-Device Identifier: 10603295016199
• UDI-Public: 10603295016199
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K072963
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2023

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: 1221-32-252
• Device Catalogue Number: 122132252
• Device Lot Number: M2706Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2023
• Supplement Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2023
• 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 LIP LNR 32IDX52OD; CORAIL AMT COLLAR SIZE 13; DELTA CER HEAD 12/14 32MM +1; PINN SECTOR W/GRIPTION 52MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown