MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*NRH REPL HINGE PIN/XSM/SM; BONE SCREWS AND PINS : KNEE TIBIAL INSERT ACCESSORY

Model Number	62-1640
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Pain (1994); Joint Laxity (4526)
Date of Event	03/17/2023
Type of Reportable Event	Serious Injury
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
Patient of (b)(4) will be revised as lps inlay right side fractured again.Revision will be for pain and instability.Revision is planned.
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 was received and stated that the patient experienced pain and instability.A surgical time extension of approximately 30 minutes also occured due to the pronounced periarticular calcifications.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.All available photos were reviewed, and no evidence of implant fracture, disassociation, or anything indicative of a device nonconformance was found.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot product code: 621640.Lot number: j5965a.1) quantity manufactured: 5 2) date of manufacture: 10/29/2019 3) any anomalies or deviations identified in dhr: no non-conformances or manufacturing irregularities were identified.4) expiry date: 09/30/2029 5) ifu reference: ifu-0902-00-787 device history review product code: 621640 lot number: j5965a.1) quantity manufactured: 5 2) date of manufacture: 10/29/2019 3) any anomalies or deviations identified in dhr: no non-conformances or manufacturing irregularities were identified.4) expiry date: 09/30/2029 5) ifu reference: ifu-0902-00-787 a manufacturing record evaluation was performed for the finished device product description: 621640 product code: srom*nrh repl hinge pin/xsm/sm lot number: j5965a and no non-conformances or manufacturing irregularities were identified.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : through follow up it is now understood there is no allegation associated against a product malfunction.The device associated with this report was returned for analysis.Visual analysis revealed found nothing indicative of a device nonconformance or a relation of the product with the reported adverse event.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot :product code: 621640.Lot number: j5965a.Quantity manufactured:(b)(4).Date of manufacture: 10/29/2019.Any anomalies or deviations identified in dhr: no non-conformances or manufacturing irregularities were identified.Expiry date: 09/30/2029.Ifu reference: ifu-0902-00-787.A manufacturing record evaluation was performed for the finished device product description: 621640; product code: sromnrh repl hinge pin/xsm/sm; lot number: j5965a and no non-conformances or manufacturing irregularities were identified.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.All available photos were reviewed, and no evidence of implant fracture, disassociation, or anything indicative of a device nonconformance was found.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot: product code: 621640, lot number: j5965a.1) quantity manufactured: (b)(4), 2) date of manufacture: 10/29/2019, 3) any anomalies or deviations identified in dhr: no non-conformances or manufacturing irregularities were identified.4) expiry date: 09/30/2029, 5) ifu reference: ifu-0902-00-787.Device history review: product code: 621640, lot number: j5965a.1) quantity manufactured: (b)(4), 2) date of manufacture: 10/29/2019, 3) any anomalies or deviations identified in dhr: no non-conformances or manufacturing irregularities were identified.4) expiry date: 09/30/2029, 5) ifu reference: ifu-0902-00-787.A manufacturing record evaluation was performed for the finished device product description: 621640 product code: srom*nrh repl hinge pin/xsm/sm lot number: j5965a and no non-conformances or manufacturing irregularities were identified.

• Common Device Name: BONE SCREWS AND PINS : KNEE TIBIAL INSERT ACCESSORY
• 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16712062
• Report Number: 1818910-2023-07629
• Device Sequence Number: 20648869
• Product Code: JWH
• UDI-Device Identifier: 10603295179108
• UDI-Public: 10603295179108
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K870730
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 04/11/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 62-1640
• Device Catalogue Number: 621640
• Device Lot Number: SO2045598
• 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: 04/06/2023
• Supplement Date Received by Manufacturer: 05/05/2023; 05/22/2023; 06/08/2023; 06/16/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 05/11/2023; 05/23/2023; 06/09/2023; 06/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2019
• 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: LPS UNIV TIB HIN INS XSM 16MM; LPS UNIV TIB HIN INS XSM 16MM; SROM*NRH REPL HINGE PIN/XSM/SM; UNK KNEE FEMORAL HINGE PIN LPS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 110 KG