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

Catalog Number UNK HIP FEMORAL STEM

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Code Available (3191)

Event Date 02/01/2012

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, "the use of femoral struts and impacted cancellous bone allograft in patients with severe femoral bone loss who undergo revision total hip replacement" written by m.A.Buttaro, j.Costantini, f.Comba, and f.Piccaluga published by the journal of bone and joint surgery vol.94-b, no.2, february 2012 was reviewed for mdr reportability.The article identifies two cases with depuy products and adverse events that received femoral struts and impacted cancellous bone allograft in conjunction with depuy products.No other depuy products were identified.This complaint captures the 2nd identified case of a (b)(6) year old woman with a depuy c-stem implanted replacing an old charnley stem.After further literature article review, it was determined the charnley is depuy's and that it failed due to loosening.The article does not identify acetabular components if any present.Radiographs do not reveal acetabular implants.She also received "incorrectly positioned strut allograft" at the time of c-stem implantation and then suffered a transverse peri-prosthetic fracture of the femur at six months post-operatively.The c-stem was removed and replaced with a long stem bypassing fracture using "the in-cement technique preserving the proximal cement mantle" along with osteosynthesis plates.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision depuy synthesof 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 number 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.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.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 9158188
• MDR Text Key: 164088334
• Report Number: 1818910-2019-107896
• 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: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR