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

Catalog Number UNK HIP FEMORAL AUGMENT

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); 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, ¿the revision femur: a potpourri of options.An alternative to distal fixation¿ by h.U.Cameron, mb, chb, frcsc, published by orthopedics (2000), vol.23, no.9, pp.957-958, was reviewed for mdr reportability.This article compares results of the s-rom long stem vs.The s-rom primary stem used in revision surgery over a 2-10 year follow up.95 patients were implanted with the primary stem and 140 patients were implanted with the long stem.The author does not include information regarding the make or manufacturer of the cup, liner, or head.This complaint captures the events and harms attributed to the two s-rom stem types.Results: primary stem: there were no removals or revisions of this stem.9 patients reported chronic pain.There were serial radiologic identifications of osteolysis of the femur and 1 loosening of the femoral stem.This patient died before revision surgery of unrelated causes.20% of patient experienced a moderate to severe limp.Long stem results: there were 7 removals or revisions in this group: 5 removals due to sepsis and 2 revisions due to aseptic loosening of the stem.15 patients reported persistent pain of the groin, buttock, thigh, or femur.38.4% of patients reported a moderate or severe limp.Serial radiographic studies identified femoral osteolysis.There were 2 cases of non-union of the trochanter and 2 cases of dysesthesia.Captured in this complaint: 1 s-rom primary stem and segment for loosening.7 s-rom long stems and augments for loosening.The complications and additional surgeries associated with the unknown acetabular components are not included within this complaint.The purpose of this study was a post-revision comparison of s-rom femoral stem types.The revised components were unknown and not included in this complaint.

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).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.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 AUGMENT
• Type of Device: HIP FEMORAL AUGMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9222090
• MDR Text Key: 176506726
• Report Number: 1818910-2019-108176
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL AUGMENT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/02/2019
• Initial Date FDA Received: 10/22/2019
• Supplement Dates Manufacturer Received: 11/14/2019
• Supplement Dates FDA Received: 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention