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

Catalog Number UNK HIP FEMORAL STEM

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003)

Patient Problems Pain (1994); Injury (2348); Osteolysis (2377); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671); Not Applicable (3189); No Code Available (3191)

Event Date 11/07/2012

Event Type  malfunction  

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, ¿nineteen year results of tha using modular 9 mm s-rom femoral component in patients with small femoral canals¿ by michael drexler, md, et al, published by the journal of arthroplasty (2013), vol.28, pp.1667-1670, was reviewed.A retrospective analysis was undertaken of 30 consecutive tha performed in 25 patients with hypoplastic proximal femurs, who had received a 9-mm uncemented modular s-rom stem between 1987 and 1999.Implanted products: s-rom total hip arthroplasty- 9-mm stem, press-fit cup, polyethylene liner, and 28 or 22-mm femoral heads.Results: 14 patients had persistent limp.2 hips had activity-related meld thigh pain that did not require medication.2 stems showed signs of loosening on serial radiographic studies- not revised.11 cases of femoral osteolysis- no revision required.Confirmed on serial radiographs.14 hips showed femoral stress shielding on serial radiographs.8 hips with heterotopic ossification confirmed on serial radiographs.6 revisions for acetabular cup loosening.5 revisions of the liner for polyethylene wear.As previously reported in (b)(4), stem subsidence was seen within the first six months in two hips, one requiring revision at 6 and 13 years respectively after initial surgery.One patient with arthrogryposis sustained a femoral shaft fracture sustained in a fall in the immediate postoperative phase; the stem was upsized to an 11mm stem and the fracture was stabilized with a femoral plate (this hip was excluded from revision analysis).No further revision surgery has been required since the previous report.These events were excluded from this complaint.They are captured on (b)(4).Captured in this complaint: s-rom femoral stem and sleeve, s-rom cup, s-rom polyethylene liner, s-rom femoral head.".

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.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.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.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.

Manufacturer Narrative

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.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.Additional information: evaluation codes patient code 3189 - used to capture limb asymmetry and extraskeletal ossification.

Manufacturer Narrative

Product complaint # (b)(4).

• 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: 9243121
• MDR Text Key: 177145103
• Report Number: 1818910-2019-108653
• Device Sequence Number: 1
• Product Code: KWA
• 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,Followup,Followup
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• 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: 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention