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

Catalog Number UNK HIP FEMORAL STEM

Device Problems Inadequacy of Device Shape and/or Size (1583); Failure to Osseointegrate (1863)

Patient Problems Pain (1994); Sepsis (2067); Injury (2348); Osteolysis (2377); 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, ¿proximal femoral fixation when bone stock allows¿ by h.U.Cameron, mb, chb, frcsc, published by seminars in arthroplasty (2011), vol.22, pp.110-111, was reviewed for mdr reportability.A prospective cohort study of s-rom stems in hip revision cases has now reached 20 years.Implanted products: 119 s-rom primary stem and 262 s-rom type ii long stems.Acetabular components and femoral heads are unknown.Results of the primary stem: three had trochanteric nonunion, and one patient had a ¿too-long leg¿.One stem was removed because of sepsis at 9 years.Results of the type ii long stem: there were numerous preoperative problems, including 12 periprosthetic fractures and 11 trochanteric non-unions.Eight had a ¿too-long leg¿.Complications included 10 greater trochanter fractures, 5 calcar fractures, 1 distal perforation, and 1 drop foot.There were 17 dislocations, of which 16 (6.1%) became recurrent and required revision to a constrained liner.The manufacturer of these components is unknown therefore, the dislocations are not included within this complaint.Four stems were removed for sepsis at a mean time of 2.3 years.There were 10 cases of aseptic loosening (3.8%).Four stems were dependent on strut grafts and failed.One stem was undersized, and one had a nonunion of a subtrochanteric osteotomy.Three had failure of ingrowth and required removal at 4, 7, and 10 years.In both groups, 18.5% had a postoperative limp.2.6% had groin pain and 3.5% had greater trochanter pain.There was one case of distal osteolysis of the femur, the type of s-rom stem associated was unspecified within the article.In the long stem group, some of the stems were implanted with cement from an unknown manufacturer.

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.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.If information is obtained that was not available for the initial 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 46581 0988
• MDR Report Key: 9251867
• MDR Text Key: 173992266
• Report Number: 1818910-2019-109014
• 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: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• 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