MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN MAR +4 10D 28IDX44OD; HIP ACETABULAR INSERT/LINER

Catalog Number 121928144

Device Problems Disassembly (1168); Material Disintegration (1177); Fracture (1260); Device Dislodged or Dislocated (2923); Naturally Worn (2988); Noise, Audible (3273)

Patient Problems Adhesion(s) (1695); Pain (1994); Joint Dislocation (2374); No Information (3190); No Code Available (3191)

Event Date 04/29/2015

Event Type  Injury  

Event Description

Patient was revised to address squeaking in the hip.It was also noted that the liner was found to be disassociated.

Manufacturer Narrative

(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Examination of the returned femoral head and acetabular liner confirm disassociation in vivo.A search of the complaints databases identified no other reports against the acetabular liner or cup product/lot code combinations.Review of the liner device history records finds no related manufacturing deviations or anomalies that would have contributed to the reported event.The root cause is undetermined and the investigation has found no product contribution to the reported event.Based on the inability to determine root cause, the need for corrective action has not been indicated.Depuy considers the investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.

Event Description

Litigation records received.Litigation alleges pain and squeaking in the hip.Radiograph images revealed that the prosthetic head in the cup showed findings consistent with significant polyethylene wear or failure.

Manufacturer Narrative

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

Event Description

Ppf alleges dislocation.

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.H10 additional narrative: h6 patient code: no code available (3191) was used to capture surgical intervention and joint injury.

Event Description

After review of medical records, patient was revised to addressed failure right total hip arthroplasty.A standard posterior approach to the hip was made.The piriformis short external rotator tendons could not be identified in the posterior scar.There was extensive omentalis of the greater trochanteric bursa.All blackened tissue was excised.The polyethylene was loose in the cup.There is a piece of polyethylene in the anterior portion of the joint which was removed.

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 +4 10D 28IDX44OD
• Type of Device: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 4748636
• MDR Text Key: 5885742
• Report Number: 1818910-2015-20052
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK033273
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor,consumer,distributor,he
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/29/2015

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 Expiration Date: 12/15/2014
• Device Catalogue Number: 121928144
• Device Lot Number: D88FX1000
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/26/2015
• Initial Date Manufacturer Received: 05/26/2015
• Initial Date FDA Received: 05/05/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; 04/19/2018; 09/05/2018; 04/01/2019; 07/16/2020; 07/20/2021
• Supplement Dates FDA Received: 05/27/2015; 12/17/2015; 04/25/2018; 09/21/2018; 04/23/2019; 07/20/2020; 08/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELTA CER HEAD 12/14 28MM +1.5; PINN BANTAM W/GRIPTION 44MM
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 78