MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR LIP LNR 32IDX52OD; HIP ACETABULAR INSERT/LINER

Model Number 1219-32-252

Device Problem Noise, Audible (3273)

Patient Problems Fatigue (1849); Pain (1994); Joint Swelling (2356); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671)

Event Date 02/22/2016

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Jul 20, 2017: litigation received.Litigation alleges pain, popping and clicking, decreased daily activities, fatigue and swelling.

Manufacturer Narrative

No device associated with this report was received for examination.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pfs also alleges limited mobility and ambulation difficulties.After review of medical records for mdr reportability, it was stated that the patient was revised to address pain.

Manufacturer Narrative

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. udi: (b)(4).

Event Description

Ppf alleges loosening of stem.

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.

• Brand Name: PINN MAR LIP LNR 32IDX52OD
• Type of Device: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6805032
• MDR Text Key: 83052829
• Report Number: 1818910-2017-23203
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295014188
• UDI-Public: 10603295014188
• Combination Product (y/n): N
• PMA/PMN Number: K000306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2012
• Device Model Number: 1219-32-252
• Device Catalogue Number: 121932252
• Device Lot Number: BN1JN1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 63