MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN BANTAM W/GRIPTION 44MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-30-044
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Dislocation of polyethylene, when the head contacted with the cup, part of the cup was ate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.
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: a2 (age), b5, d6a and h6 (device code).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h4.
Event or Problem Description
Additional information received: a.What is the affected side? right hip.B.Was surgery time extended? no.C.What do you mean '' part of the cup was ate?'' please elaborate.The pinnacle cup was eaten for the head.Port of the cup disappear., i can imagen that has happened for the friction between metal part of the cup and ceramic 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the device associated with this report was received for examination.Based on visual analysis of the provided evidence along with observation on involved devices, it was possible to identify a disassociation event among cup and liner.Also, a remarkable worn condition was observed on the inner surface of the cup.An advanced degradation of the metal material was present, consequence of the ceramic interaction to onto this area.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Drawing/specifications reviewed? n/a.Dimensional inspection: n/a.Device history lot : a manufacturing record evaluation was performed for the finished device: j08z57 (p/n: 121730044) and no non-conformances or manufacturing irregularities related to the malfunction were identified.Device history review : a manufacturing record evaluation was performed for the finished device (121730044/j08z57) product and lot numbers, and no non-conformances were identified.

• Brand Name: PINN BANTAM W/GRIPTION 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
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15418261
• Report Number: 1818910-2022-17900
• Device Sequence Number: 19488097
• Product Code: KWA
• UDI-Device Identifier: 10603295009948
• UDI-Public: 10603295009948
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K093646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/14/2022

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: 1217-30-044
• Device Catalogue Number: 121730044
• Device Lot Number: J08Z57
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2022
• Supplement Date Received by Manufacturer: 09/21/2022; 09/29/2022; 02/22/2023
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 09/28/2022; 10/03/2022; 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELTA CER HEAD 12/14 28MM +5; PINN MAR +4 10D 28IDX44OD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Unknown