MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR LIP LNR 32IDX54OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number 1219-32-254

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

Patient Problems Pain (1994); Joint Disorder (2373)

Event Date 11/27/2019

Event Type  Injury  

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

Patient received her primary total hip in 2017.Revised today due to the patient being unhappy with a leg length discrepancy.Pain, irritation with leg length discrepancy.

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 : no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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: PINN MAR LIP LNR 32IDX54OD
• 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: 9490567
• MDR Text Key: 179249470
• Report Number: 1818910-2019-123855
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295014195
• UDI-Public: 10603295014195
• Combination Product (y/n): N
• PMA/PMN Number: K000306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/27/2019

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 Model Number: 1219-32-254
• Device Catalogue Number: 121932254
• Device Lot Number: C88371
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/27/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 01/31/2020
• Supplement Dates FDA Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention