MAUDE Adverse Event Report: DEPUY IRELAND 9616671 CORAIL AMT COLLAR SIZE 8; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number 3L92498

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).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.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

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).

Event Description

Additional information was received and stated that during the revision procedure, the surgeon found metallosis throughout 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.

• Brand Name: CORAIL AMT COLLAR SIZE 8
• Type of Device: CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• 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: 15986152
• MDR Text Key: 305496764
• Report Number: 1818910-2022-25479
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295168645
• UDI-Public: 10603295168645
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192946
• 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
• 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: 07/16/2012
• Device Model Number: 3L92498
• Device Catalogue Number: 3L92498
• Device Lot Number: 2402630
• 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
• Supplement Dates FDA Received: 12/23/2022; 05/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• 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