MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 300 ACET CUP 58MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-03-058
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.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
It was reported that the patient had an infected hip, which happened to be metal on metal, surgeon conducted an i&d and replaced liner and head.After review of medical records patient was revised to addressed pain and infection.Operative notes findings of gross left hip purulence tracked just distal and anterior to the gluteal sling, along the calcar where there was some bone loss and up the iliopsoas bursa.Evidence of metallosis staining at areas in the synovium.There was metal debris behind the liner.Significant amount of overhanging bone anterior and superior with the cup and very little anteversion.Doi: (b)(6) 2006.Dor: (b)(6) 2018; left hip.
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 manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: PINNACLE 300 ACET CUP 58MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11541018
• Report Number: 1818910-2021-05704
• Device Sequence Number: 17270912
• Product Code: LPH
• UDI-Device Identifier: 10603295008682
• UDI-Public: 10603295008682
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2021

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 Model Number: 1217-03-058
• Device Catalogue Number: 121703058
• Device Lot Number: AD6FY1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 03/30/2021
• 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: APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +8.5; PINNACLE 300 ACET CUP 58MM; PINNACLE MTL INS NEUT36IDX58OD; TRI-LOCK TI 12.5 LAT OFFSET; APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +8.5; PINNACLE 300 ACET CUP 58MM; PINNACLE MTL INS NEUT36IDX58OD; TRI-LOCK TI 12.5 LAT OFFSET
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR