MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX +4 10D 36IDX54OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number 122136154

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Weakness (2145)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Pfs and medical records received.Pfs alleges pain and weakness after first revision.After review of medical records, there is no revision reported.Doi: (b)(6) 2015 (head, liner); doi: (b)(6) 2007 (cup,screw, stem,sleeve); dor: none reported (left hip).Please see (b)(4) for the left hip first revision.

• Brand Name: ALTRX +4 10D 36IDX54OD
• Type of Device: 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: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9484125
• MDR Text Key: 177161192
• Report Number: 1818910-2019-123663
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295016410
• UDI-Public: 10603295016410
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/25/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 122136154
• Device Lot Number: 402576
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2013
• 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
• Patient Outcome(s): Required Intervention