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

Catalog Number UNK HIP FEMORAL STEM

Device Problems Loose or Intermittent Connection (1371); Osseointegration Problem (3003)

Patient Problems Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 03/08/2008

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, ""tha using an anatomic stem in patients with femoral head osteonecrosis"" written by yong-chan ha md, hee joong kim md, shin-yoon kim md, tae-young kim md, and kyung-hoi koo md published by clinical orthopaedics and research published only 8 march 2008 was reviewed.The article's purpose was to determine long term survivorship of thas with anatomic stems in patients with femoral head osteonecrosis, the amount and rate of wear, and the incidence of osteolysis.The data was compiled from 36 patients (46 hips) with mean age of 48.6 years and follow up 10 years.Depuy products utilized: all femoral stems were depuy profile stems with ha coating, duraloc cups enduron poly liner and cocr heads.It is noted radiographic images captured 3 different patients with identifiers and they are captured individually on linked complaints." this complaint captures the (b)(6) man in figure 4a-c who is noted to have extensive femoral osteolysis and cavitary osteolysis around the cup osteolysis.Narrative description provides details that she was revised for loosening of the femoral component.In the introduction, the article attributes osteolysis as "polyethylene particle-induced" which is commonly attributed to bearing surfaces, but the article fails to mention any confirmation of debris intra-operatively.The article does provide liner wear rates.

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.H10 additional narrative: corrected: h6 (closure codes and device codes).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.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 STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9254006
• MDR Text Key: 173992386
• Report Number: 1818910-2019-112965
• Device Sequence Number: 1
• Product Code: KXA
• 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: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR