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

Catalog Number UNK HIP ACETABULAR CUP

Device Problems Material Separation (1562); Device Dislodged or Dislocated (2923)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Injury (2348); Joint Disorder (2373); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 04/23/2019

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.

Event Description

Luxation of right pe-inlay 6 years after implantation.Date of revision: (b)(6) /2019.

Manufacturer Narrative

Udi: (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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 associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Primary operative notes (b)(6) 2012 indicate the patient received a right total hip replacement due to coxarthosis.The surgery was completed without indication of complication by the surgeon.Revision operative notes (b)(6) 2019 indicate the patient received a right hip revision of the head and inlay, debridement to the bone and biopsy via transgluteal access due to inlay luxation, bald trochanter with inserted total hip replacement.Indication for the procedure reveals the patient was experiencing painful immobility.Upon entering the joint, it is indicated that the joint capsule is calloused and thickened.An aspiration of darkly stained joint fluid in relation to metal debris was completed.Inlay disassociation is confirmed.Head and inlay were replaced and heterotopic ossification ventrally at the greater trochanter was removed.The surgery was completed without indication of complication by the surgeon.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.  h10 additional narrative:  udi: (b)(4).Added: b5, b7 and h6(patient and device codes).

• Brand Name: UNKNOWN HIP ACETABULAR CUP
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8822761
• MDR Text Key: 152079557
• Report Number: 1818910-2019-99156
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/04/2019
• Initial Date FDA Received: 07/24/2019
• Supplement Dates Manufacturer Received: 08/01/2019; 08/01/2019; 09/17/2019
• Supplement Dates FDA Received: 08/05/2019; 08/26/2019; 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR