MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR UNI FEMORAL IMPL SIZE 47; ASR HIP SYSTEM : HIP METAL FEMORAL HEADS

Catalog Number 999890247

Device Problem Naturally Worn (2988)

Patient Problems Cyst(s) (1800); Death (1802); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Distress (2329); Discomfort (2330); Injury (2348); Ambulation Difficulties (2544); Test Result (2695)

Event Date 04/15/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the patient had an asr cup,sleeve and head done over 10 years ago in (b)(6).The surgeon took out asr head sleeve and cup, and put in new pinnacle multihole shelll, screw, liner and head.Doi: over 10 years ago; dor: (b)(6) 2019; left hip.

Event Description

Plaintiffs claim damages as a result of injury due to decedent's failed depuy asr hip implant, including economic damages and wrongful death.After the implantation, the decedent suffered the following personal and economic injuries as a result of the implantation with the asr hip implant: severe pain, elevated metal levels, emotional injuries, trouble sleeping and walking, and ultimately death.

Manufacturer Narrative

Product complaint (b)(4).Added death determination (b2), additional information in event description (b5), and patient code (h6).The information pertaining to the death was received from a litigation source only.No further information is available at this time.An additional supplemental report will be submitted if more information is received.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.

Manufacturer Narrative

Product complaint # (b)(4).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.Device history lot : previous investigations that have included manufacturing record evaluations (mre) since the asr platform was launched have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.

Event Description

Patient experienced fatigue and has inflammation.Revision notes stated that there was a large hemorrhagic cyst.The hemarthrosis and sanguinous filled cyst was drained.There was also erosion of bone of the superior and posterior acetabulum.There was also some erosion of the upper femur with some hairline nondisplaced fracture of the greater trochanter and bone loss on the acetabulum.Doi: (b)(6), 2009, dor: (b)(6), 2019, (left hip).

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative:  added: a4, b5, b7,d4 (expiration date), d10, h6 (clinical code).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d6a, h5.

Manufacturer Narrative

Product complaint # (b)(4).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.Device history lot: previous investigations that have included manufacturing record evaluations (mre) since the asr platform was launched have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.H10 additional narrative: added: h6.

• Brand Name: ASR UNI FEMORAL IMPL SIZE 47
• Type of Device: ASR HIP SYSTEM : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10022886
• MDR Text Key: 189825448
• Report Number: 1818910-2020-11638
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K040627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/15/2019

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 Expiration Date: 06/30/2019
• Device Catalogue Number: 999890247
• Device Lot Number: 2952930
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/17/2020
• Initial Date FDA Received: 05/04/2020
• Supplement Dates Manufacturer Received: 04/17/2020; 06/25/2021; 06/29/2021; 07/20/2021
• Supplement Dates FDA Received: 05/06/2020; 06/28/2021; 07/19/2021; 07/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: ADAPTER SLEEVES 12/14 +5; ASR ACETABULAR CUPS 54; SUMMIT POR TAPER SZ4 STD OFF
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 90