MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE BANTAM ACET CUP 44MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-20-044
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Patient was revised to treat pain, bone loss, and metallosis secondary to polywear and debris.Doi: (b)(6) 2017, dor: (b)(6) 2021, unk hip.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: the device associated with this report was not received for examination.Examination of the provided photographs and devices that were returned on this complaint found evidence to support disassociation of the liner from the cup while implanted.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 info be received, 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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.H6 medical device problem code: appropriate term/code not available (a27) used to capture incident.

• Brand Name: PINNACLE BANTAM ACET CUP 44MM
• 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: 12275395
• Report Number: 1818910-2021-17006
• Device Sequence Number: 11541259
• Product Code: LPH
• UDI-Device Identifier: 10603295009580
• UDI-Public: 10603295009580
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1217-20-044
• Device Catalogue Number: 121720044
• Device Lot Number: H12595
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/04/2021
• Supplement Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 08/24/2021
• 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: DELTA CER HEAD 12/14 28 MM +5.; PINN CAN BONE SCREW 6.5 MMX20 MM.; PINN MAR +4 10D 28IDX44OD.; PINNACLE BANTAM ACET CUP 44 MM.; SUMMIT POR TAPER SZ4 STD OFF.; DELTA CER HEAD 12/14 28 MM +5; PINN CAN BONE SCREW 6.5 MMX20 MM; PINN MAR +4 10D 28IDX44OD; PINNACLE BANTAM ACET CUP 44 MM; SUMMIT POR TAPER SZ4 STD OFF
• Patient Age: 78 YR
• Patient Weight: 59