MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR LIP LNR 28IDX56OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number 1219-28-256

Device Problems Naturally Worn (2988); Noise, Audible (3273)

Patient Problems Adhesion(s) (1695); Pain (1994); 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

Surgeon reported to bfarm: "increasing pain in the right hip without trauma after getting up and audible cracking; preoperative radiological: ceramic head fracture after hip tep 15 years ago; intraoperatively: the most likely older event with fragments that are firmly encapsulated in the capsule / scar tissue, some freshly lying in the joint.".

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned liner finds nothing outward to suggest product error or any contribution to the reason for revision.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 28IDX56OD
• 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: 10146951
• MDR Text Key: 194942470
• Report Number: 1818910-2020-13701
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295013648
• UDI-Public: 10603295013648
• Combination Product (y/n): N
• PMA/PMN Number: P070026
• 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: 06/01/2020

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: 1219-28-256
• Device Catalogue Number: 121928256
• Device Lot Number: Y24E41000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Initial Date Manufacturer Received: 06/01/2020
• Initial Date FDA Received: 06/12/2020
• Supplement Dates Manufacturer Received: 08/18/2020
• Supplement Dates FDA Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELTA CER HEAD 12/14 28MM +8.5; PINN MAR LIP LNR 28IDX56OD; DELTA CER HEAD 12/14 28MM +8.5; PINN MAR LIP LNR 28IDX56OD
• Patient Outcome(s): Required Intervention
• Patient Age: 92 YR