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

Catalog Number 999890353

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

Patient Problems Foreign Body Reaction (1868); Pain (1994); Anxiety (2328); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360); Osteolysis (2377); Thrombosis/Thrombus (4440); Metal Related Pathology (4530)

Event Date 07/10/2013

Event Type  Injury  

Event Description

Litigation papers allege pain, discomfort, and elevated metal ion levels.Update: 07/15/13: plaintiff¿s preliminary disclosure form was received, which identified dob and part/lot information.The complaint and associated mdrs were updated.There was no new information that would change the outcome of the investigation.

Manufacturer Narrative

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

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.

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.

Event Description

Additional information was received and stated that during the revision procedure, the surgeon found metallosis throighout the hip.Post - revision surgery, the patient experienced anxiety about all the damage that the asr has caused.Doi: (b)(6) 2008.Dor: (b)(6) 2022.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, b6, b7.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h6 (clinical code).

• Brand Name: ASR TAP SLV ADAP 12/14 -1
• 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
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15986150
• MDR Text Key: 305496484
• Report Number: 1818910-2022-25478
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/15/2022

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: 03/17/2013
• Device Catalogue Number: 999890353
• Device Lot Number: 2582717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 12/23/2022; 05/10/2023; 05/16/2023
• Supplement Dates FDA Received: 12/23/2022; 05/15/2023; 05/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2008
• 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 46; ASR TAP SLV ADAP 12/14 -1; ASR UNI FEMORAL IMPL SIZE 41; CORAIL AMT COLLAR SIZE 8
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 100 KG