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

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Necrosis (1971); Joint Dislocation (2374); No Code Available (3191); Joint Laxity (4526)

Event Date 06/24/2019

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

The literature article entitled, "effect of articular capsule repair on postoperative dislocation after primary total hip replacement by the anterolateral approach" written by yiran lu, zongming wu , xianzhong tang, mengzhen gu and bo hou published by journal of international medical research accepted by publisher on 24 june 2019 was reviewed.The article's purpose to assess articular capsule repair in primary total hip replacement with the anterolateral approach and its effect on postoperative dislocation.Data was compiled from total 385 patients that were followed up for up to 5 years.All patients received depuy products.Depuy products: pinnacle cup, corail uncemented ha stem, head, liner.Figures 1-3 provide photographic images of the surgical procedure with no adverse events reported.Figure 4 provides radiographic images reporting a (b)(6) year old man who experienced a post op dislocation with symptoms of joint instability treated by manual reduction.Narrative description reports the dislocation occurred during functional exercise after arthroplasty and he soon experienced a cerebral infarction resulting in hemiplegia on the affected side.Generalized adverse events: dislocations (treated by closed reduction).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary = no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.

• 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: 10843581
• MDR Text Key: 216353250
• Report Number: 1818910-2020-24682
• 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: 11/02/2020

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 FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/02/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 12/23/2020
• Supplement Dates FDA Received: 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention