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

Catalog Number UNK HIP ACETABULAR CUP

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 04/18/2020

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

The literature article entitled, "acetabular liner dissociation: a comparative study of two contemporary uncemented acetabular components" written by david p.Gwynne-jones, ma, bm, bch, frcs, fracs (orth) and adeel memon, frcs published by arthroplasty today accepted by publisher on 18 april 2020 was reviewed.The article's purpose was to compare experience with 2 similar contemporary third-generation modular acetabular components used over the same time period from the same center.Data was compiled from two groups with the first group containing depuy products.All products were uncemented.Within group 1, revisions for disassociation were captured by patient with patient identifiers in table 2.This complaint captures the generalized adverse events for group one and the 6 individualized patients with identifiers.Depuy products of group 1: corail stem, pinnacle cup, metal head, poly liner.Generalized adverse events: recurrent dislocations and instability (treated by revision).Deep infection (treated by debridement and exchange of head and liner).Loose uncemented stem (treated by revision).Individuals with revision for disassociation: (b)(6) years old male received liner change 12.3 months post implantation.(b)(6) years old male received liner change 13.1 months post implantation.(b)(6) years old male received liner change 4.43 months post implantation.(b)(6) years old male received cemented liner in existing cup and stem revision for impingement 58.3 months post implantation.(b)(6) years old male received liner change 130 months post implantation.(b)(6) years old female received liner change 5 months post implantation.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Review of the attached images confirmed the acetabular cup is mispositioned.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 : no lot number available for lot search.H10 additional narrative: added: b1 (product problem).

Event Description

Examination made by investigator on the provided x-ray image finds that the acetabular cup is mispositioned, having almost no anteversion.

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.H10 additional narrative:  added b5 and h6.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• 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: 10541961
• MDR Text Key: 207525331
• Report Number: 1818910-2020-20247
• Device Sequence Number: 1
• Product Code: LPH
• 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,Followup
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• 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: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention