MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CORAIL AMT COLLAR SIZE 10; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number	3L92500
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).(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
Compass case (b)(4) report: revised due to infected right hip.Loosening component was the stem.All implants were removed and a temporary spacer was implanted.Dor: (b)(6) 2021, doi: (b)(6) 2016, loosening interface: non-cemented.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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 material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: CORAIL AMT COLLAR SIZE 10
• Common Device Name: CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12487369
• Report Number: 1818910-2021-20370
• Device Sequence Number: 16981823
• Product Code: LZO
• UDI-Device Identifier: 10603295168669
• UDI-Public: 10603295168669
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K190344
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2021

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 Expiration Date: 05/31/2021
• Device Model Number: 3L92500
• Device Catalogue Number: 3L92500
• Device Lot Number: 5273353
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 09/17/2021
• Supplement Report FDA Received Date: 10/03/2021
• 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 32IDX48OD; CORAIL AMT COLLAR SIZE 10; DELTA CER HEAD 12/14 32MM +1; PINN CAN BONE SCREW 6.5MMX25MM; PINN SECTOR W/GRIPTION 48MM; ALTRX NEUT 32IDX48OD; CORAIL AMT COLLAR SIZE 10; DELTA CER HEAD 12/14 32MM +1; PINN CAN BONE SCREW 6.5MMX25MM; PINN SECTOR W/GRIPTION 48MM
• Outcome Attributed to Adverse Event: Required Intervention