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

Catalog Number UNK HIP FEMORAL STEM

Device Problem Corroded (1131)

Patient Problems Bone Fracture(s) (1870); Hypersensitivity/Allergic reaction (1907); Pain (1994); No Code Available (3191)

Event Date 11/14/2014

Event Type  Injury  

Manufacturer Narrative

Product complaint #
=
> (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, "greater trochanteric fragmentation after failed metal-on-metal hip arthroplasty" written by phonthakorn panichkul, md; kevin b.Fricka, md; robert h.Hopper jr, phd; and c.Anderson engh jr, md published by orthopedics.2015; 38(5):e447¿e451.Doi:10.3928/01477447-20150504-93 on 4 november 2014 was reviewed for mdr reportability.The article reports upon 2 cases.Only patient #2 is identified with depuy products.Patient is (b)(6) woman implanted with pinnacle cup and prodigy stem.She presented 3 years post initial implant with pain and swelling.Aspiration revealed "milky type, low viscosity fluid" and she received a left hip revision 39 months post initial implant.A solid mass removed, corrosion on the ball and stem were seen.The "modular metal liner and ball were changed" to mop bearing surface."histopathologic examination revealed necrotic tissue with chronic inflammation and perivascular lymphocytic infiltrates consistent with a mom reaction." she then experienced 2 dislocation treated with closed reduction at 2 and 12 months after revision.The article reports: the patient had 2 dislocations that required closed reduction at 2 and 12 months after revision.Thirteen months after revision, fragmentation of the greater trochanter was noted radiographically (figures 3b-e).Fourteen and 19 months after revision, she had febrile episodes associated with pain and swelling of her hip.An aspiration was negative for infection.The patient sustained a third dislocation, and the decision was made to convert her to a constrained liner 24 months after her initial revision.At her most recent evaluation, the patient had a painless range of motion, a negative trendelenburg¿s sign, and no limp." adverse events: corrosion on ball & stem, foreign body reaction, pain, soft tissue necrosis, hypersensitivity, surgical intervention, joint dislocation, fracture (post op).Impacted products: acetabular liner (metal), femoral head (metal).

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.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.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.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.Visual examination of the provided x-ray images found no evidence of implant fracture, disassociation, or anything indicative of a device non-conformance.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.Device history lot: null.Device history batch: null.Device history review: null.

• 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: 9137582
• MDR Text Key: 166390713
• Report Number: 1818910-2019-106876
• 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: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• 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: 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention