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); Pain (1994); Not Applicable (3189); No Code Available (3191)

Event Date 05/18/2015

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, ¿do revised hip resurfacing arthroplasties lead to outcomes comparable to those of primary and revised total hip arthroplasties?¿ by william desloges md, et al, published by clinical orthopaedic related research (2012), vol.470, pp.3134-3141, was reviewed.The purposes of this study was to determine (1) patients undergoing hr revision have perioperative measures and outcome scores comparable to those of patients undergoing primary tha and patients undergoing revision of primary tha and (2) patients undergoing revision of both the femoral and acetabular components of an hr have perioperative measures and outcome scores comparable to those of patients undergoing revision of the hr femoral component only.This article reviews the outcomes of revision surgery using competitor products.In this study, the only depuy product included was 1 asr hemiarthroplasty that was revised.This complaint captures the reasons for revision of the asr cup and head.Results: 1 asr cup revised for loosening, pain, and pseudotumor 1 asr head revised for femoral neck fracture, loosening, and pseudotumor there was no metallosis found at time of revisions surgery.The authors do not mention any bearing wear found on the explanted components or indicate an increase in blood ion levels.".

Manufacturer Narrative

Product complaint (b)(4).Added h6 patient code: not applicable (3189) used to capture medical device removal.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.Investigation summary : this hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.No device associated with this report was received for examination.The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Wwcapa 00780, which was later superseded by mdd capa-001226, was established to investigate root cause and/or corrective actions.Reference: mdd capa-001226.Previous investigations that have included device history reviews since the asr platform was launched have shown no indication of deviations or anomalies with regard to material, manufacturing, or inspection.Therefore, no device history record (dhr) review for this individual asr component will be carried out at this point in time.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction wi-7915 appendix a.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.The root cause(s) and or corrective action(s) are documented in mdd capa-001226.No evidence was found indicating product error was a contributing factor.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• 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: 9243395
• MDR Text Key: 174225381
• Report Number: 1818910-2019-112414
• 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,Followup
• Report Date: 10/04/2019

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 HEAD
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/04/2019
• Initial Date FDA Received: 10/27/2019
• Supplement Dates Manufacturer Received: 10/04/2019; 11/18/2019
• Supplement Dates FDA Received: 10/28/2019; 11/20/2019
• 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