MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Bone Fracture(s) (1870); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Test Result (2695); No Code Available (3191)

Event Date 02/04/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number.The correction/removal reporting number listed applies to the corresponding product code sold domestically.(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

The literature article entitled, "superior patient reported outcome measures reported post articular surface replacement (asr) revision arthroplasty in the setting of an objective surgical indication" written by andrew j.Hughes, mark curtin, evelyn murphy, william curtin, and colin g.Murphy published by journal of orthopaedics made available online 04 february 2020 was reviewed.The article's purpose was to further analyze previously studied revision cases to explore outcomes post asr revision.Data was compiled from 36 revisions in 35 patients.Cement manufacturer is not identified.Both asr and asr xl systems were used in primaries but femoral stem is not identified.If patients had asr xl total hip arthroplasty system fund well fixed, an extended trochanteric osteotomy was performed and repaired in situ thereafter with either cables or a greater trochanteric plate and implanted with uncemented collared corail stems.Also at revision, uncemented pinnacle gription acetabular shells with or without screw fixation were implanted, but bearing surface materials were not discussed within the article for revision implants.The article does not report any adverse events associated with implants utilized during revision.Therefore, this complaint captures the revision reasons for the depuy asr and asr xl implants that were retrieved and identified.Depuy products: asr head, asr cup, asr xl head, asr xl cup, asr xl sleeve (augment).Reasons for revision with no further information provided: pain.Loosening.Alval.Elevated ions.Infection.Fracture.

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 code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10291359
• MDR Text Key: 199461848
• Report Number: 1818910-2020-16192
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention