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

Catalog Number UNK HIP ACETABULAR CUP

Device Problems Use of Device Problem (1670); Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2012

Event Type  malfunction  

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.(b)(4).

Event Description

The literature article entitled, "autogenous impaction grafting in total hip arthroplasty with developmental dysplasia of the hip" written by huiwu li md, phd, liao wang md, phd, kerong dai md, and zhenan zhu md, phd published by the journal of arthroplasty 28 (2013) 637-643 accepted by publisher 2 july 2012 was reviewed.The article's purpose was to analyze midterm results of patients diagnosed with developmental dysplasia of the hip who received acetabular reconstruction utilizing tha.Data was compiled from 68 patients (78 hips; 63 women, 5 men) with follow up range of 4-7 years.Depuy and non depuy products were implanted.The article does not identify which specific products were associated with the adverse events.The article does not provide adequate information to determine accurate quantities.Depuy products utilized: duraloc cups, bearing couple metal-on-poly and ceramic-on-ceramic, femoral head, uncemented stems.Adverse events: dislocation 3 months after implantation caused by patient squatting (treated by open reduction).Leg length discrepancy greater than 1.5 cm (no impact on function).Heterotopic ossification (no impact on function).Misposition cups (inclination range 38-58 degrees by radiographic detection without indication of intervention).

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 CUP
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9607327
• MDR Text Key: 189240523
• Report Number: 1818910-2020-02275
• 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: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2020
• Is this an Adverse Event Report?: No
• 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: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1