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

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Nonstandard Device (1420); Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Articular surface replacement of the hip: a prospective single surgeon series¿ by s.S.Jameson et al.(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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

An article ¿articular surface replacement of the hip: a prospective single surgeon series¿ by s.S.Jameson et al reports on the early clinical and radiological results of articular surface replacement (asr) resurfacings and the description of the experience of using the asr prosthesis.Between april 2004 and september 2006, 214 consecutive hips in 192 patients (129 hips in 114 males, 85 hips in 78 females).The mean follow-up was 43 months and the mean age was 56 years.Narrowing of the neck was noted in 124 hips.A (b)(6)-year-old female (case 9) with early failure of the femoral head or neck had a femoral revision to an uncemented thr comprising a modular asr xl (depuy international ltd) head and an s-rom (depuy international ltd) femoral stem.Implant was in-situ for 47 months underwent revision due to persistent pain and metal wear debris.At revision, gross swelling of pseudocapsule caused by accumulation of fluid was observed.Tissue necrosis and synovial ulceration was also seen.Increasing groin pain at three years was observed and acetabular component loose at revision.The anteversion and inclination angles were 27°/52°.The head/acetabular component size were 46/52 mm.The femoral position, in terms of neck-shaft angle, stem-neck angle and stem-shaft angle were 136°, 14°,150°.Asr hip implant was found to be associated with above reported adverse events.Impacted product: unknown hip acetabular cup (asr), unknown hip femoral head (asr).Patient code: surgical intervention, pain, accumulation of fluid, foreign body reaction, tissue necrosis, synovial ulceration, and inadequate osseointegration.Product experience code: implant position - mispositioned (unknown hip acetabular cup)-for acetabular cup malposition.Implant loosening/ bone to implant (unknown hip acetabular cup) ¿ for acetabular cup loosening.Implant bearing wear-metal (unknown hip acetabular cup and unknown hip femoral head) ¿ for metal debris.

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).Investigation summary: the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.The investigation regarding the root cause(s) and/or corrective actions was conducted under mdd capa-001226.Ongoing post market surveillance is conducted per our procedures for this product.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 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: 8891059
• MDR Text Key: 154288250
• Report Number: 1818910-2019-101064
• Device Sequence Number: 0
• Product Code: KXA
• 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: 08/07/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2019
• 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
• Patient Age: 45 YR