MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 CORAIL2 NON COL HO SIZE 9; HIP FEMORAL STEM

Model Number	L20309
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(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
Pc was created to captured the left hip.On (b)(6) 2011, the patient had a left total hip arthroplasty to address left hip arthroplasty to address left hip arthritis.Depuy components were used during this procedure.No complications were noted during the procedure.(part/lot page 250 of 302).On (b)(6) 2018, the patient had a revision left total hip arthroplasty, to address failed left total hip arthroplasty, wear of articular bearing surface, and elevated of serum cobalt and chromium.The ceramic femoral head and metal liner were revised.Depuy components were implanted during this procedure along with competitor cement.The surgeon reports that due to excessive acetabular anteversion, the patient has developed elevations of cobalt and chromium.The patient reported experiencing subluxation.Prior to surgery the patient had an aspiration, which was noted to suggest infection, yet a repeat aspiration negated that diagnosis.During the surgery, the surgeon observed black synovial fluid (which was later diagnosed as metallosis).A single screw was left in place as the head had stripped, the remaining screws were removed.The cup was left insitu as the surgeon felt they could correct the misposition with a liner.The surgeon then roughed up the acetabular cup with a saw blade and created several notches in the posterior surface of the new poly liner for competitor cement placement.(sticker sheet page 261 of 302).Doi: (b)(6) 2011 dor: (b)(6) 2018 left hip.(b)(4) for right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary the device was not returned.All available images were reviewed.There is no depuy's product failure reported or a relation between the adverse event and the reported product.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 9
• 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13290656
• Report Number: 1818910-2022-01186
• Device Sequence Number: 19935713
• Product Code: KWA
• UDI-Device Identifier: 10603295258001
• UDI-Public: 10603295258001
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K070554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2022

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: 08/01/2013
• Device Model Number: L20309
• Device Catalogue Number: L20309
• Device Lot Number: 2707441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2022
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 01/19/2022
• Supplement Report FDA Received Date: 03/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2008
• 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: CORAIL2 NON COL HO SIZE 9; DELTA CER HEAD 12/14 36MM +1.5; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN SECTOR W/GRIPTION 52MM; PINNACLE MTL INS NEUT36IDX52OD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female