MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 ACET CUP 54MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-01-054
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Discomfort (2330); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/22/2021
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
Customer is reporting a disassociation of inlay from cup.Head was reaming at the inner part of the cup.Unknown side affected.Doi: unknown, dor: (b)(6) 2021 - revision of inlay and head.
Additional Manufacturer Narrative
Product complaint( b)(4) this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5 and h6 (patient) if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
On (b)(6) 2021, the patient dislocated with "luxation of the head in the cup with inlay dislocation." metallosis was found as well as a tilted inlay for unknown reason.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received indicated that discomfort occurred in the right hip as well as mechanical sounds.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Investigation summary: no device associated with this report was received for examination.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: 8.2) date of manufacture: 22-sep-2017.3) any anomalies or deviations identified in dhr: 2 parts from this lot were scrapped.Scrap code a040: this concerns ¿contamination¿.There is no correlation between this scrap reason and the failure mode of the complaint.4) expiry date: 31-aug-2027.5) ifu reference: 090200701.

• Brand Name: PINNACLE 100 ACET CUP 54MM
• 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: 11436581
• Report Number: 1818910-2021-04600
• Device Sequence Number: 4076908
• Product Code: LPH
• UDI-Device Identifier: 10603295008569
• UDI-Public: 10603295008569
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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,Followup,Followup
• Report Date (Section B): 02/23/2021

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: 1217-01-054
• Device Catalogue Number: 121701054
• Device Lot Number: 8631594
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 02/23/2021; 03/18/2021; 05/19/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 03/12/2021; 03/24/2021; 05/19/2021
• 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.; CORAIL2 STD SIZE 12.; HIP BALL BIOLOX 32 +1 12/14.; PINN MAR NEUT 32IDX54OD.; PINNACLE 100 ACET CUP 54MM.; APEX HOLE ELIM POSITIVE STOP; CORAIL2 STD SIZE 12; HIP BALL BIOLOX 32 +1 12/14; PINN MAR NEUT 32IDX54OD; PINNACLE 100 ACET CUP 54MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 68