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

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Corroded (1131); Device Dislodged or Dislocated (2923)

Patient Problems Foreign Body Reaction (1868); Unspecified Infection (1930); Pain (1994); Joint Dislocation (2374); Osteolysis (2377); No Code Available (3191)

Event Date 10/12/2016

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

"literature article entitled, ¿metal-on-metal compared with metal-on-polyethylene: the effect on trunnion corrosion in total hip arthroplasty¿ by brent a.Lanting, md, et al, published by the journal of arthroplasty (2017), vol.32, pp.2574-2579, was reviewed for mdr reportability.The purpose of this study is to quantify and subsequently compare the material loss in mop- to mom-retrieved total hips secondary to corrosion.The effect of head diameter on trunnion corrosion will also be examined.Finally, how time in vivo affects material loss will also be examined to provide guidance in monitoring tha patients.This is a retrospective retrieval study of explanted components.Implants: depuy pinnacle 36-mm mom cup with articul/eze 36-mm metal heads (42) and depuy articul/eze mop system with 36-mm articul/eze metal heads (29).There were mop and mom competitor systems analyzed in this study, as well.All trunnions were 12-mm/14-mm design.The femoral stem manufacturer is unknown.Results: there was evidence of corrosion on the tapers of heads in both the mop and mom group.Reasons for revision in the mop group: 10 infections, 6 for loosening of the acetabular component, 5 dislocations, 4 for instability, 2 for pain, 1 fracture (unspecified), 1 for acetabular subsidence.Reasons for revision in the mom group: 27 for ¿metal reaction¿ the authors do not give details about they types or severities of the metal reactions: 6 for infection, 4 for acetabular loosening, 2 for osteolysis, 1 for pain, 1 for dislocation, 1 for fracture unspecified.The explanted components were analyzed for evidence of corrosion on the taper surfaces of the femoral heads.There is no further detail provided regarding patient harms or adverse events attributed to the components within the text of this article.There was no retrieval of the femoral stems within this study.".

Manufacturer Narrative

Product complaint # (b)(4).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.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.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.Per internal procedures, the event information was reviewed.No investigational inputs were received.For this investigation, no immediate action was required as no alleged deficiency with the device was identified.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.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Investigational inputs were requested as indicated per internal procedures for this failure mode, however, no information was provided to depuy without the physical complaint sample associated with this report, it was not possible to determine if the device failed to meet specifications at the time it was released for distribution.The device associated with this event was used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No evidence was found indicating product error was a contributing factor.The need for corrective action was not indicated.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.

• 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: 9214731
• MDR Text Key: 176331089
• Report Number: 1818910-2019-109328
• 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: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention