MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CEMENTRALIZER 13.0; HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG

Model Number	1376-22-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/18/2021
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.Investigation summary: no device associated with this report was received for examination.No revision has been reported.Examination of the provided x-ray images finds nothing indicative of a product problem.The information received will be retained for potential series investigations if triggered by trend analysis 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.
Event or Problem Description
Patient has now been revised to address a confirmed infection with explantation of all products.This including the use of an opening femoral osteotomy to facilitate removal of the femoral stem.An antibiotic spacer was re-implanted to address the infection.Event is possibly related to device and not related to procedure.Date of implant:(b)(6) 2012; date of event: (b)(6) 2021; (right hip).
Event or Problem Description
Patient has now been revised to address a confirmed infection with explantation of all products.This including the use of an opening femoral osteotomy to facilitate removal of the femoral stem.An antibiotic spacer was re-implanted to address the infection.All devices are considered reportable, given that it is not possible to rule-out their possible contribution, given that they present a safe harbor for infectious microorganisms to take hold.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.No revision has been reported.Examination of the provided x-ray images finds nothing indicative of a product problem.The information received will be retained for potential series investigations if triggered by trend analysis 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 devices have been implanted for more than eight years and no revision has been reported.It is not likely an error in the material, manufacturing, inspection or sterile processing would be a contributing factor in the reported allegations.A manufacturing records evaluation (mre) was not performed.

• Brand Name: CEMENTRALIZER 13.0
• Common Device Name: HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11855012
• Report Number: 1818910-2021-10759
• Device Sequence Number: 3854654
• Product Code: LTO
• UDI-Device Identifier: 10603295034469
• UDI-Public: 10603295034469
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K871510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1376-22-000
• Device Catalogue Number: 137622000
• Device Lot Number: 287245
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 05/25/2021
• 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: 12/14 ARTICUL 40MM M SPEC+8.5; ALTRX +4 NEUT 40IDX58OD; APEX HOLE ELIM POSITIVE STOP; CEMENTRALIZER 13.0; PINNACLE 100 ACET CUP 58MM; SUMMIT CEMENTED STEM SZ6 HI; 12/14 ARTICUL 40MM M SPEC+8.5; ALTRX +4 NEUT 40IDX58OD; APEX HOLE ELIM POSITIVE STOP; CEMENTRALIZER 13.0; PINNACLE 100 ACET CUP 58MM; SUMMIT CEMENTED STEM SZ6 HI
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Weight: 106