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

Catalog Number UNK HIP ACETABULAR CUP

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

Patient Problems Foreign Body Reaction (1868); Pain (1994); Osteolysis (2377); No Code Available (3191)

Event Date 04/28/2020

Event Type  Injury  

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

The literature article entitled, "protrusion of a ceramic femoral head through the acetabular metallic cup in total-hip arthroplasty a case report" written by ding zhao, md, de-bao zhang, md, dong-feng han, md, and gui-shan gu, md published by medicine accepted by publisher on 28 april 2020 was reviewed.The article reports on one case of a (b)(6) male who received tha in 2010 in right hip with titanium 50 mm acetabular cup, poly liner, size 8 trilock bps stem, 28 mm femoral ceramic head (all implants from depuy) underwent a revision in 2018.Article notes he did not perform follow ups and often participated in strenuous sports activities including mountain climbing and long distance running.He reported pain since 2017 in right groin.By june 2018 the pain increased and radiographs revealed internal superior subluxation of the head within the cup.Intraoperative findings were a disassociated liner which lead to the liner being impinged with femoral neck.The liner had portions completely worn through leading the ceramic head in direct contact with the femoral cup leading to the cup being worn through as well.Intraoperative findings also include black pigmentation of metallic debris within osteolytic lesions and around the joint capsule and acetabulum.All components were removed including the stem and replaced with new depuy implants.No further complications.The article provides photographic images for illustrative purposes.Depuy products: poly liner, titanium cup, trilock stem, ceramic head.Adverse events: disassociation of liner from cup (root cause which lead to poly liner wear, metal wear and metallic debris) - treated by revision of all components.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Review of the attached images and x-rays confirmed the reported complaint.The root cause could not be determined.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.

• Brand Name: UNKNOWN HIP ACETABULAR CUP
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10879595
• MDR Text Key: 217640923
• Report Number: 1818910-2020-25179
• 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: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR