MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 CORAIL2 NON COL HO SIZE 10; HIP FEMORAL STEM

Model Number	L20310
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Inadequate Osseointegration (2646)
Date of Event	04/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision completed to address pain.Patient has presented in the past year or two with pain in the femoral area.Bone scans and x-rays show increased uptake around the femoral stem and progressive radiolucent lines.A decision was taken revise the femoral stem and replace the mom liner with a dual mobility.The femoral stem was found to be loose.Non overt evidence of metallosis was present.The stem was removed quite easily, the metal pinnacle liner removed and replaced with a pinnacle dual mobility liner and the stem replaced with a zb arcos stem.
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.
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
Additional information received.A.What was the actual reason for the primary surgery? not known.The primary surgery date was 12-may-2010.B.Was there any adverse consequence to the patient during the revision surgery? if yes, please kindly provide details.None reported.The patient was revised due to a loose femoral stem.C.Was there a surgical delay? if yes, what is the duration of the delay? no delay reported.D.What is the affected side involved in this event? right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = the device associated with this complaint was not received for examination.The photo investigation cannot confirm the reported allegation.Nothing indicative of a device nonconformance was found.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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.

• Brand Name: CORAIL2 NON COL HO SIZE 10
• Common Device Name: 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 69801 ; FR 69801
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14354765
• Report Number: 1818910-2022-08614
• Device Sequence Number: 11786748
• Product Code: LZO
• UDI-Device Identifier: 10603295258018
• UDI-Public: 10603295258018
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K190344
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/11/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: L20310
• Device Catalogue Number: L20310
• Device Lot Number: 5003011
• 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: 04/27/2022
• Supplement Date Received by Manufacturer: 05/16/2022; 06/29/2022; 06/30/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 05/20/2022; 06/29/2022; 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2009
• 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; ARTICULEZE M HEAD 36MM +1.5; PINNACLE 100 HA ACET CUP 58MM; PINNACLE MTL INS NEUT36IDX58OD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male