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 Problems Stroke/CVA (1770); Bone Fracture(s) (1870); Pain (1994); Sepsis (2067); Injury (2348); Inadequate Osseointegration (2646); No Code Available (3191)

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, ¿the two- to six-year results with a proximally modular noncemented total hip replacement used in hip revisions¿ by hugh u.Cameron, m.B.C.H.B, frcs©, published by clinical orthopaedic related research (1994), no.298, pp.47-53, was reviewed.A review of the two- to six-year results of revision cases using a proximally modular noncemented r-rom total hip replacement has been carried out.There were 91 cases.A primary stem was used in 29 and a long revision calcar replacement stem in 62.Implants: s-rom femoral stem with proximal sleeve, s-rom cup and liner, s-rom cocr head.Results: 1 case myositis ossificans- coded extraskeletal ossification- no revision.1 cva.4 cases non-union of the osteotomy site.12 intraoperative femur fractures treated with cerclage wires.1 intraoperative acetabular fracture treated with cerclage.1 case of severe distal stem pain treated with revision.1 acetabular cup migration- revised.1 revision of head and liner for recurrent dislocation.3 complete tha removals for sepsis- converted to girdlestone.1 revised stem for aseptic loosening.The author does not include specific patient data in this article.The author notes that pain was slight to moderate in 23% of patients following tha surgery.The myositis ossificans is attributed to the soft tissue damage associated with insertion of the tha components.The author notes that the patient¿s pain was severe initially but fully healed at 2 years-follow up.The author provided no additional information regarding the nature or treatment of the single case of postoperative cva.".

Manufacturer Narrative

Product complaint # (b)(4).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.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 not 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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: 9230291
• MDR Text Key: 176569158
• Report Number: 1818910-2019-108599
• 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
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• 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: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention