MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR CUPS 50; ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 999800750

Device Problems Failure to Osseointegrate (1863); Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Osteolysis (2377); Inadequate Osseointegration (2646); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/11/2019

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.(b)(4).

Event Description

It was reported that the patient had an asr cup removed due metallosis.Doi: unknown.Dor: (b)(6) 2019.Left hip.

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.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, a follow-up medwatch will be filed as appropriate.

Event Description

After review of medical records.It was reported that the patient revised for failed left tha, adverse reaction from a recalled metal on metal tha.Operative notes reported that there was significant osteolysis around her left hip.Metal level were obtained and were elevated, date and results were not provide.Operative notes reported that there was trunnionosis and granulomatous debris around the circumferential aspect of the acetabulum.There was significant osteolysis of the periacetabular region and there was very minimal bone stock that was left.There was a portion of posterior wall that was eroded as well as the anterior wall.Post operative finding reported severe osteolysis, adverse metal-on-metal fluid collection, well-fixed femoral stem, osteolysis involved the periacetabular region including the pubic rami and the ilium as well as a portion of the ischium and the proximal' femur.On (b)(6) 2019, the patient had a revision of the left total hip to address failed left total hip, adverse reaction/metal-on-metal, severe osteolysis.Indications for surgery included elevated metal ion levels.During the surgery, the surgeon observed trunnionosis and granulomatous debris, and osteolysis.Depuy components were used during this procedure.The femoral component was noted to be well fixed.

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.H6 health effect - clinical code: appropriate term / code not available (e2402) used to capture the blood heavy metal increased and pocket erosion.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Replaced surigcal intervention with device revision or replacement.

Manufacturer Narrative

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.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.

• Brand Name: ASR ACETABULAR CUPS 50
• Type of Device: ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 9545819
• MDR Text Key: 185200075
• Report Number: 1818910-2020-00324
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/11/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2012
• Device Catalogue Number: 999800750
• Device Lot Number: 2386867
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/11/2019
• Initial Date FDA Received: 01/03/2020
• Supplement Dates Manufacturer Received: 02/03/2020; 03/22/2021; 06/01/2021
• Supplement Dates FDA Received: 02/04/2020; 04/06/2021; 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADAPTER SLEEVES 12/14 +2; ASR ACETABULAR CUPS 50; ASR UNI FEMORAL IMPL SIZE 45; SUMMIT POR TAPER SZ2 STD OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR