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

Catalog Number 999800750

Device Problems Loss of or Failure to Bond (1068); Use of Device Problem (1670); Loss of Osseointegration (2408)

Patient Problems Adhesion(s) (1695); Cyst(s) (1800); Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Inadequate Osseointegration (2646); No Code Available (3191); Physical Asymmetry (4573); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/05/2020

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.

Event Description

The patient was revised to address pain.It was also reported that the non-cemented cup was loose.Doi: unknown.Dor: (b)(6) 2020.Affected side: left hip.

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.H10 additional narrative:.

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: h6 health effect - clinical code: appropriate term / code not available (e2402) used to capture the blood heavy metal increased, joint injury and bone injury.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Patient had elevated metal ion.Revision notes stated that scar excision was performed including removal of abnormal appearing tissue.A minimal sized fluid collection was evacuated.There was some evidence of corrosion at the trunnion.There was near impingement with extension and external rotation of the hip.The cup was too anteverted and vertical.Leg lengths looked short.Cup, head.And sleeve were removed.Operative findings stated that a local soft tissue response and fluid collection in line with an adverse metal on metal reaction was found.There are some contained bony defects on the acetabular side that twe bone grafted.There was also some posterior superior bone loss and medial.The local soft tissues were stained in a way that is characteristic for a metal on metal failure.

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.

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.

Event Description

Patient experienced discomfort, managed socks/shoes with some difficulty.Patient has enlarging supra- acetabular cyst which could be related to metal-on-metal failure.

• 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: 10061141
• MDR Text Key: 191109465
• Report Number: 1818910-2020-12138
• 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,health
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 999800750
• Device Lot Number: 2146527
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2021
• 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 +2; ASR UNI FEMORAL IMPL SIZE 45; SUMMIT POR TAPER SZ3 STD OFF; ADAPTER SLEEVES 12/14 +2; ASR UNI FEMORAL IMPL SIZE 45
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR