MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR +4 10D 36IDX52OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number 1219-36-152

Device Problem Defective Component (2292)

Patient Problems No Code Available (3191); Insufficient Information (4580)

Event Date 08/18/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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 liner was defective and not polished well after opening the package.Another like device was used to complete the surgery.There was a surgical delay of 10 minutes.The surgery was completed without complications.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned acetabular liner confirms the reported observation.The device did not meet required cosmetic requirements.The root cause has been attributed to human error within the manufacturing process.Involved associates have been made aware and retrained to requirements.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.Added: h6 (clinical code).Corrected: h3.

• Brand Name: PINN MAR +4 10D 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: 10489707
• MDR Text Key: 205552789
• Report Number: 1818910-2020-19438
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295014577
• UDI-Public: 10603295014577
• Combination Product (y/n): N
• PMA/PMN Number: K033273
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1219-36-152
• Device Catalogue Number: 121936152
• Device Lot Number: 9253063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PINN MAR +4 10D 36IDX52OD.; PINN MAR +4 10D 36IDX52OD