MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX NEUT 36IDX52OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number 1221-36-052

Device Problem Difficult to Insert (1316)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 01/13/2020

Event Type  malfunction  

Manufacturer Narrative

(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 patient underwent a routine primary total hip arthroplasty on the left side.Placement of a 52mm socket was routine.No screws were placed.Upon impaction and inspection of the 36x52 n altrex liner, it was noted that the liner was not sitting appropriately in the cup.Liner was removed, and during extraction of the liner it was decided to place one acetabular screw.A 2nd liner was placed, and once again was not seating properly.It was decided by the surgeon that the 52mm cup was questionable regarding its locking mechanism.The 2nd liner, screw, and cup were explanted and a new 54mm cup was place.All items being returned to depuy for analysis.Letter requested by the surgeon.Surgery prolonged 20 min.Doe: (b)(6) 2020, left hip.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Product complaint # (b)(4).Examination of the returned device finds nothing outward to suggest product 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.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ALTRX NEUT 36IDX52OD
• Type of Device: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9632690
• MDR Text Key: 189366493
• Report Number: 1818910-2020-03026
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295016328
• UDI-Public: 10603295016328
• Combination Product (y/n): N
• PMA/PMN Number: K102423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1221-36-052
• Device Catalogue Number: 122136052
• Device Lot Number: J60T10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Date Manufacturer Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN HIP SCREW
• Patient Age: 59 YR