MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX NEUT 36IDX58OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number 122136058

Device Problem Difficult to Insert (1316)

Patient Problem Not Applicable (3189)

Event Date 08/16/2019

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 during a routine left total hip replacement, a 58mm pinnacle socket was inserted.During impaction of the 58mmx36mm n altrex liner, it was noted that the liner would not seat correctly.The liner was removed, and subsequently a new liner was inserted.It is noted the second liner was seated appropriately and impacted.Surgery prolonged of 15 minutes.Doe: (b)(6) 2019; 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).Investigation summary: examination of the returned liner is unable to identify any product error or root cause for the problem experienced.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 36IDX58OD
• Type of Device: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8964650
• MDR Text Key: 156585666
• Report Number: 1818910-2019-103163
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295016359
• UDI-Public: 10603295016359
• Combination Product (y/n): N
• PMA/PMN Number: K062148
• 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: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 122136058
• Device Lot Number: J4093Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Date Manufacturer Received: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR