MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 CORAIL2 STD SIZE 9; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number	3L92509
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision of acetabular components of a hip-tep.Doi: unknown, dor: (b)(6) 2022, unknown side.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.
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.(the concomitant products were updated from unknown to known products and removed date of explant since the device was not removed).
Event or Problem Description
Additional information received: a.Was there any adverse consequence/s to the patient that led to the revision surgery? yes, pain when bending.B.Was there a surgical delay? if yes, what is the duration of the delay? no c.What is the affected side? right side.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Investigation summary: no device associated with this report was received for examination.The investigation could not verify or draw any conclusions about the root cause of the reported event without the device to examine.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: bfarm dhr review request: product description: corail2 std size 9.Product code: 3l92509.Lot number: 3269913.Please provide: 1) quantity manufactured: 12 parts.2) date of manufacture: 24-mar-2011.3) any anomalies or deviations identified in dhr: no.4) expiry date: 02/2016.5) ifu reference: w90942 ifu corail ii hip stem.Device history review: a manufacturing record evaluation was performed for the finished device (3l92509/corail2 std size 9) product and lot numbers, and no non-conformances were identified.

• Brand Name: CORAIL2 STD SIZE 9
• Common Device Name: CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY FRANCE SAS 3003895575; 7 allee irene joliot curie; b.p. 256; st. priest cedex 69801 ; FR 69801
• Manufacturer (Section G): DEPUY FRANCE SAS 3003895575; 7 allee irene joliot curie; b.p. 256; st. priest cedex IN 69801 ; FR 69801
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15587717
• Report Number: 1818910-2022-20217
• Device Sequence Number: 2810241
• Product Code: LZO
• UDI-Device Identifier: 10603295168751
• UDI-Public: 10603295168751
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K190344
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• 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,Followup,Followup
• Report Date (Section B): 10/12/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/16/2016
• Device Model Number: 3L92509
• Device Catalogue Number: 3L92509
• Device Lot Number: 3269913
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2022
• Supplement Date Received by Manufacturer: 10/13/2022; 10/19/2022; 11/18/2022
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 10/18/2022; 10/26/2022; 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: APEX HOLE ELIM POSITIVE STOP; HIP BALL BIOLOX 32 +5 12/14; PINN MAR +4 NEUT 32IDX50OD; PINNACLE SECTOR II CUP 50MM; UNK HIP ACETABULAR AUGMENT; UNK HIP ACETABULAR LINER POLY; UNK HIP FEMORAL HEAD CERAMIC; UNKNOWN HIP ACETABULAR CUP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female