MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR +4 10D 32IDX52OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number 1219-32-152

Device Problems Device-Device Incompatibility (2919); Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problem No Code Available (3191)

Event Date 05/06/2020

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

Total non-cemenetated hip prosthesis, implanted 4 years ago ((b)(6) 2016), reviewed for the possibility of wear of polyethylene and which is finally a dissociation of polyethylene.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information 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.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.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).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information 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.

• Brand Name: PINN MAR +4 10D 32IDX52OD
• 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: 10074907
• MDR Text Key: 191561810
• Report Number: 1818910-2020-12334
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295014058
• UDI-Public: 10603295014058
• Combination Product (y/n): N
• PMA/PMN Number: K001534
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/06/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 1219-32-152
• Device Catalogue Number: 121932152
• Device Lot Number: C52640
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/06/2020
• Initial Date FDA Received: 05/20/2020
• Supplement Dates Manufacturer Received: 06/11/2020; 06/11/2020
• Supplement Dates FDA Received: 06/12/2020; 06/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP ACETABULAR CUP
• Patient Age: 55 YR