MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE BANTAM ACET CUP 46MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-20-046
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Health Effect - Clinical Codes	Joint Laxity (4526); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
On (b)(6) 2017, the patient underwent a primary right hip arthroplasty due to advanced coxarthrosis with existing dysplasia.Depuy acetabular cup, poly liner, depuy corail stem, and metal head were implanted.There were no indicated intra-operative complications.On (b)(6) 2021, the patient underwent a right hip revision to address poly liner wear.The surgeon noted subluxation that was causing noises.The head and liner were revised.There were no indicated intra-operative complications.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.This device was manufactured on 23-nov-2016.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot : 1) quantity manufactured: (b)(4).2) date of manufacture: 23-nov-2016 3) any anomalies or deviations identified in dhr: none 4) expiry date: 31-oct-2026 5) ifu reference: 090200701.

• Brand Name: PINNACLE BANTAM ACET CUP 46MM
• 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: 12040311
• Report Number: 1818910-2021-13229
• Device Sequence Number: 11762264
• Product Code: LPH
• UDI-Device Identifier: 10603295009597
• UDI-Public: 10603295009597
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 05/18/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1217-20-046
• Device Catalogue Number: 121720046
• Device Lot Number: H12599
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 06/30/2021
• 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: ARTICUL/EZE BALL 28 +1.5 GR; CORAIL2 STD SIZE 13; PINN MAR +4 10D 28IDX46OD; PINNACLE BANTAM ACET CUP 46MM; ARTICUL/EZE BALL 28 +1.5 GR; CORAIL2 STD SIZE 13; PINN MAR +4 10D 28IDX46OD; PINNACLE BANTAM ACET CUP 46MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR