MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN LNR CON +4 10D 28IDX48OD; PINNACLE HIP SYSTEM : HIP CONSTRAINED ACETABULAR LINERS

Model Number	1218-28-748
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/22/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the constrained liner had been implanted and was sitting in the acetabular shell component.While the surgeon was trying to reduce the hip, the lip of the constrained liner was compromised.
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 (dob, age), a3, b5, d4 (expiration date).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 was received and stated that after trying to reduce the hip, the surgeon noticed that the lip of the liner had deformed (had either broken or been compromised) making it impossible to reduce the hip.The liner was not compromised when it was opened and initially implanted.The surgeon thinks this happened while trying to reduce the 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 a manufacturing record evaluation (nc search) was performed for the finished device product code:121828748, lot - j1351a and no non-conformances / manufacturing irregularities were identified.

• Brand Name: PINN LNR CON +4 10D 28IDX48OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP CONSTRAINED ACETABULAR LINERS
• 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: 17092581
• Report Number: 1818910-2023-11928
• Device Sequence Number: 20527165
• Product Code: KWZ
• UDI-Device Identifier: 10603295011521
• UDI-Public: 10603295011521
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K043058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2023

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 Expiration Date: 10/31/2023
• Device Model Number: 1218-28-748
• Device Catalogue Number: 121828748
• Device Lot Number: J1351A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2023
• Supplement Date Received by Manufacturer: 06/15/2023; 07/10/2023
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 06/20/2023; 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Female