MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR TAP SLV ADAP 12/14 -1; FEMORAL SLEEVE

Catalog Number 999890353

Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360); Osteolysis (2377); Swelling/ Edema (4577)

Event Date 11/16/2022

Event Type  Injury  

Event Description

The patient suffered severe pain and discomfort, increased metal levels in her blood including cobalt and chromium, permanent injuries, emotional distress, disability, and disfigurement as a result of the implantation with her right asr hip implant.Doi: (b)(6) 2009.Dor: (b)(6), 2022.Right hip.

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.E3 initial reporter occupation: lawyer.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.Investigation summary: no device associated with this report was received for examination.The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: device history reviews for asr platform have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4) investigation summary - no device associated with this report was received for examination.The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot - device history reviews for asr platform have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.H10 additional narrative: added: e1.

Event Description

On (b)(6) 2022 the surgeon discovered there was a large fluid-filled capsular extension to the area.The capsule was opened and was noted to have a large amount of cloudy yellow-white fluid with some debris within it.The pseudocapsule was noted to be inflamed.There was metal debris around the neck of the stem.There was osteolysis tracked into the canal but about 15mm.There was osteolysis noted by the calcar.There were areas behind the cup that had some metal debris.

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: b1 (is product problem), b5, d4 (lot, expiration date), g4, h4 and h6 (clinical codes).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.D1, d2, d4 (catalog, udi), d10 and h6 (device code).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary = no device associated with this report was received for examination.The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.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: ASR TAP SLV ADAP 12/14 -1
• Type of Device: FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18284339
• MDR Text Key: 329956299
• Report Number: 1818910-2023-24882
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/07/2023

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: 01/30/2013
• Device Catalogue Number: 999890353
• Device Lot Number: 2543063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: 12/05/2023; 01/05/2024; 01/12/2024
• Supplement Dates FDA Received: 12/11/2023; 01/10/2024; 01/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: ASR ACETABULAR CUPS 48.; ASR UNI FEMORAL IMPL SIZE 43.; SUMMIT POR TAPER SZ6 STD OFF.; UNK HIP ACETABULAR CUP ASR.; UNK HIP FEMORAL HEAD METAL ASR.; UNKNOWN HIP FEMORAL STEM.
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female