MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Sepsis (2067); Injury (2348); Osteolysis (2377); No Code Available (3191)

Event Date 04/18/2001

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

The literature article entitled, ""cementless total hip arthroplasty in young chinese patients" written by k.Y.Chiu, fhkam (ortho surg), w.M.Tang, fhkam (ortho surg), t.P.Ng, fhkam (ortho surg), k.C.Poon, frcs (ed), w.Y.Ho, frcs (ed), and k.M.Lee, afrcse (ed) published by the journal of arthroplasty vol.16 no.7 2001 doi:10.1054/arth.2001.25505 on 18 april 2001 was reviewed for mdr reportability.The article reports that 27 patients out of 51 received depuy aml implants with the remainder being non depuy.The 27 patients with aml implants had 9 aml acetabular components implanted before 1991 and the remainder 18 had duraloc acetabular components thereafter.The femoral heads were 28 mm in diameter for the aml hips.No further information given regarding materials.Clinical outcomes for the 51 patients include mild pain that did not limit activities (4); revisions (10) for the following reasons: aseptic loosening unspecified anatomical location (1), poly wear with osteolysis (7), late sepsis (2).The article further states: "the acetabular component alone was revised in 2 hips; the acetabular component and the femoral component were revised in 3 hips; the polyethylene liner and the hip ball were exchanged without changing the metal acetabular component or the femoral component in 5 hips.The reoperation rate did not differ significantly between (non depuy product) and aml hips (p 5.53)" the article does not specify which products are related to the clinical outcomes or adverse events.The article notes on radiographic findings: heterotopic ossification was noted in a total of 25 hips out of 51 hips total, 43 hips demonstrated some degree of stress shielding, osteolytic lesions were found around 4 aml acetabular components and 8 femoral components.The article consistently reports no differences of rates or percentages for adverse events between aml and the non-depuy counterpart which indicates that at least one or more of the aforementioned adverse events can be associated with at least one or more depuy aml or duraloc products but exact quantities are unknown.

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).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.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 will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9154302
• MDR Text Key: 162457434
• Report Number: 1818910-2019-107375
• 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,literature
• Type of Report: Initial,Followup
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention