MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ADAPTER SLEEVES 12/14 +5; ASR HIP SYSTEM : HIP FEMORAL SLEEVE

Catalog Number 999800315

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/20/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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

The patient was revised due to failed mom hip replacement causing pain, elevated chromium ion level and joint effusion.Mri reported acetabular component appears to be vertical and possible retroverted.Without significant pseudotumor and adverse local tissue reaction.Operative notes reported scar tissues, normal appearing synovial fluid in the hip joint, scarring of the gluteus medius was noted.Some taper corrosion was noted on the trunnion this was removed.There was no loosening, the stem was stable.There was some defective bone grafted from local bone on the posterior superior of the acetabular component.Scar tissue and synovium were removed.Doi: (b)(6) 2009; dor: (b)(6) 2018: 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.Device history lot: device history reviews for asr platform have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.

• Brand Name: ADAPTER SLEEVES 12/14 +5
• Type of Device: ASR HIP SYSTEM : HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 11497504
• MDR Text Key: 240140213
• Report Number: 1818910-2021-05233
• 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: other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2013
• Device Catalogue Number: 999800315
• Device Lot Number: 2773019
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/23/2021
• 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 300 SPIKED CUP SIZE 52; ASR UNI FEMORAL IMPL SIZE 46; SUMMIT POR TAPER SZ4 STD OFF; ADAPTER SLEEVES 12/14 +5; ASR 300 SPIKED CUP SIZE 52; ASR UNI FEMORAL IMPL SIZE 46; SUMMIT POR TAPER SZ4 STD OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR