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

Catalog Number UNK HIP ACETABULAR LINER

Device Problems Fracture (1260); Noise, Audible (3273)

Patient Problem No Code Available (3191)

Event Date 09/14/2019

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.(b)(4).

Event Description

Literature article entitled, ¿ceramic liner fracture in ceramic on ceramic total hip arthroplasty: a case report¿ by eknath d.Pawar, et al, published by international journal of surgery case reports (2019), vol.65, pp.242-244, was reviewed.The purpose of this article was to review a case of ceramic liner fracture 30 months after primary implantation.A (b)(6) male presented to the er with squeaking of the left hip after a bilateral tha to treat natural avascular necrosis.Radiographs revealed a fracture of the 32 mm biolox ceramic neutral liner.Intraoperatively, all liner fragments were removed, and the articulation was replaced with a ceramic head and polyethylene liner.The cup and stem were well-fixed and retained.Depuy products: biolox delta 32 mm +9 ceramic femoral head and biolox 32 mm neutral liner.Captured in this complaint: liner: implant fracture post op, implant noise.Femoral head: implant noise.Patient harms: device revision or replacement.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary: no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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.

• 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: 9972659
• MDR Text Key: 188367149
• Report Number: 1818910-2020-10911
• Device Sequence Number: 1
• Product Code: KWY
• 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: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR