MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR UNI FEMORAL IMPL SIZE 51; ASR HIP SYSTEM : HIP METAL FEMORAL HEADS

Catalog Number 999890251

Device Problems Corroded (1131); Degraded (1153); Naturally Worn (2988); Noise, Audible (3273)

Patient Problems Host-Tissue Reaction (1297); Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Pocket Erosion (2013); Swelling (2091); Tissue Damage (2104); Discomfort (2330); Injury (2348); Joint Disorder (2373); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)

Event Date 07/17/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.No pma/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.Concomitant medical products: asr uni femoral impl size 51 hip asr femoral head; asr acetabular cups 58 hip asr acetabular cup; adapter sleeves 12/14 +5 hip asr femoral sleeve/augment; summit duofix tap sz4 hi off hip femoral stem.Initial reporter occupation: non-healthcare professional ¿ attorney.(b)(4).

Event Description

New unity record created in order to update etq complaint number (b)(4).Patient was revised to address removal of the asr for unknown reason.It also states that patient had other side revised.It was mom liner.Update ad 25 oct 2018: (b)(4) is a re-opened record of (b)(4) due to receipt of litigation records.Litigation alleged increasing pain, swelling, elevated levels of cobalt and chromium in the patient's bloodstream, injury, discomfort, poor balance, difficulty walking, popping, clicking and grinding noises, bone erosion, femoral acetabular loosening, impingement and/or detachment, metallosis, emotional distress and suffering.Added patient harms, added stem as per new allegation of "elevated levels of cobalt and chromium in the patient's bloodstream." and affected hip.Doi: (b)(6) 2009; dor: (b)(6) 2017; right hip.

Manufacturer Narrative

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(b)(4).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.

Manufacturer Narrative

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.H10 additional narrative: added: b1, h6 (patient).Corrected: h6 (device).H6 patient code: no code available (3191) was used to capture emotional distress.Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and 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.

Manufacturer Narrative

Product complaint # (b)(4).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 caused or contributed to the potential event described in this report.No code available use for device revision or replacement.

Event Description

After review of medical records patient was revised to addressed failed right total hip arthroplasty with trunnionosis and abductor necrosis.Operative notes indicated consistent pseudotumor formation, fluid stained and extensive evidence of metal debris, minimal bone loss and evidence of corrosion at the taper and bearing surface of femoral head.Added expiration date, medical history and date of birth of patient.Corrected patient's initial.Doi: (b)(6) 2009 dor: (b)(6) 2017 right hip.

• Brand Name: ASR UNI FEMORAL IMPL SIZE 51
• Type of Device: ASR HIP SYSTEM : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 8083958
• MDR Text Key: 127543463
• Report Number: 1818910-2018-75870
• 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: other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 999890251
• Device Lot Number: 2864993
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2020
• 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
• Patient Age: 68 YR