MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL AMT SZ10 135 HIGH COL; CORAIL LINE EXTENSION IMPLANTS : HIP FEMORAL STEM

Model Number	L971110
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	08/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Revision due to aseptic loosening.Patient experienced pain.
Additional 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
1.Can you confirm the primary surgery date or the original implantation date? (b)(6) 2010.2.Can you please provide the date the patient was revised? (b)(6) 2021.3.What is the affected side involved in this event? right.4.Please provide the loosening interface of the loose stem.Bone / implant.5.Please provide the product and lot number of all explanted products.Na.6.Was there any suggestion by anyone indicating that there was or may be deficiency with the other product(s)? if yes please ensure details.No.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Device history lot : a worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.

• Brand Name: CORAIL AMT SZ10 135 HIGH COL
• Common Device Name: CORAIL LINE EXTENSION IMPLANTS : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex IN 69801 ; FR 69801
• MDR Report Key: 12485941
• Report Number: 1818910-2021-20345
• Device Sequence Number: 3349778
• Product Code: LZO
• UDI-Device Identifier: 10603295455295
• UDI-Public: 10603295455295
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K190344
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: L971110
• Device Catalogue Number: L971110
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 09/21/2021; 10/13/2021
• Initial Report FDA Received Date: 09/16/2021
• Supplement Report FDA Received Date: 09/22/2021; 10/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARTICULEZE M HEAD 36MM +8.5; CORAIL AMT SZ10 135 HIGH COL; PINNACLE MTL INS NEUT36IDX52OD; ARTICULEZE M HEAD 36MM +8.5; CORAIL AMT SZ10 135 HIGH COL; PINNACLE MTL INS NEUT36IDX52OD
• Patient Age: 80 YR