MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL AMT SZ11 STD COL; OTHER PRODUCTS

Model Number	L971211
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Joint Laxity (4526)
Date of Event	01/01/2020
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 tha: corail pinnacle revised to c-stem pinnacle due to undetected intra-operative posterior calcar fracture, resulting in post-operative stem subsidence.Corail extracted, c-stem implanted, pinnacle liner exchanged due to range of motion instability.No surgical delay.Procedure completed successfully.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Review of the attached images could not confirm the reported allegations.A root cause could not be determined.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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.Corrected: d2 and g1.

• Brand Name: CORAIL AMT SZ11 STD COL
• Common Device Name: OTHER PRODUCTS
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 10884979
• Report Number: 1818910-2020-25205
• Device Sequence Number: 16432657
• Product Code: LPH
• UDI-Device Identifier: 10603295478621
• UDI-Public: 10603295478621
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K102423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2020

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
• Operator of Device: Health Professional
• Device Model Number: L971211
• Device Catalogue Number: L971211
• Device Lot Number: 9337956
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/08/2020
• Supplement Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 11/23/2020
• Supplement Report FDA Received Date: 01/25/2021
• 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: ALTRX NEUT 32IDX50OD.; ARTICUL/EZE BALL 32 +1 GR.; ALTRX NEUT 32IDX50OD; ARTICUL/EZE BALL 32 +1 GR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR