MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS

Catalog Number UNK HIP ACETABULAR LINER

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Pain (1994); Joint Dislocation (2374); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/10/2020

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

Polyethylene break after 10 months of intervention.In the metallic part of the cup no deficiency was seen macroscopically.The dislocated, worn and broken polyethylene was found.The head was 32mm depuy ceramic.It was changed in revision surgery.

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.

Event Description

On (b)(6) 2020, patient had undergone a revision on the right total hip arthroplasty due to fractured polyethylene.The operative note is not available at the time of review.The devices used for this procedure were also unknown at the time of review.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.In review of the provided x-ray images a disassociation event appears evident.It is also noted that the position of the acetabular cup appears more vertical than would be recommended by depuy.The information received will be retained for potential series investigations if triggered by trend analysis 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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.H6 health effect - clinical code: appropriate term / code not available (e2402) used to capture the injury (e20).Corrected: h6.Removed clinical code joint dislocation and joint instability.Removed device code implant dislocation and was changed to implant disassociation.

Event Description

After secondary review of the provided x-ray images a disassociation event appears evident.A dislocation event is not depicted.It is also noted that the position of the acetabular cup appears more vertical than would be recommended by depuy.

• Brand Name: UNKNOWN HIP ACETABULAR LINERS
• Type of Device: HIP ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10741576
• MDR Text Key: 213246044
• Report Number: 1818910-2020-23388
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR LINER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (CORAIL STEM); PINNACLE SECTOR II CUP 50MM; UNK HIP BONE SCREW; UNK HIP BONE SCREW; UNKNOWN HIP FEMORAL HEAD; (CORAIL STEM); PINNACLE SECTOR II CUP 50MM; UNK HIP BONE SCREW; UNK HIP BONE SCREW; UNKNOWN HIP FEMORAL HEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 62