MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS XSM 16MM; LPS AND S-ROM : KNEE TIBIAL INSERT

Model Number	1987-27-116
Medical Device Problem Code	Fracture (1260)
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.
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 occurred due to the pronounced periarticular calcifications.
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 complaint was not returned.Photo evidence and x-rays provided were reviewed and found evidence of fracture of the lps univ tib hin ins xsm 16mm.The report allegation can be confirmed.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: 198727116.Lot number: j3940j.1) quantity manufactured: 8, 2) date of manufacture: 5/29/2019, 3) any anomalies or deviations identified in dhr: no non-conformances or manufacturing irregularities were identified.4) expiry date: 04/30/2024, 5) ifu reference: ifu-0902-00-773.Device history review: 1) quantity manufactured: 8, 2) date of manufacture: 5/29/2019, 3) any anomalies or deviations identified in dhr: no non-conformances or manufacturing irregularities were identified.4) expiry date: 04/30/2024, 5) ifu reference: ifu-0902-00-773.A manufacturing record evaluation was performed for the finished device product.Description: lps univ tib hin ins xsm 16mm product code: 198727116, lot number: j3940j and no non-conformances or manufacturing irregularities were identified.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was returned for analysis.Visual analysis revealed that fracture of the lps univ tib hin ins xsm 16mm.The report allegation can be confirmed.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: 198727116.Lot number: j3940j.1) quantity manufactured: (b)(4).2) date of manufacture: 5/29/2019.3) any anomalies or deviations identified in dhr: no non-conformances or manufacturing irregularities were identified.4) expiry date: 04/30/2024.5) ifu reference:ifu-0902-00-773.Device history review: 1) quantity manufactured: (b)(4).2) date of manufacture: 5/29/2019.3) any anomalies or deviations identified in dhr: no non-conformances or manufacturing irregularities were identified.4) expiry date: 04/30/2024.5) ifu reference:ifu-0902-00-773.A manufacturing record evaluation was performed for the finished device product description: lps univ tib hin ins xsm 16mm product code: 198727116 lot number: j3940j and no non-conformances or manufacturing irregularities were identified.Corrected h3.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this complaint was not returned.Photo evidence and x-rays provided were reviewed and found evidence of fracture of the lps univ tib hin ins xsm 16mm.The report allegation can be confirmed.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: 198727116.Lot number: j3940j 1) quantity manufactured: (b)(4) 2) date of manufacture: 5/29/2019 3) any anomalies or deviations identified in dhr: no non-conformances or manufacturing irregularities were identified.4) expiry date: 04/30/2024 5) ifu reference:ifu-0902-00-773 device history review: 1) quantity manufactured: (b)(4) 2) date of manufacture: 5/29/2019 3) any anomalies or deviations identified in dhr: no non-conformances or manufacturing irregularities were identified.4) expiry date: 04/30/2024 5) ifu reference:ifu-0902-00-773 a manufacturing record evaluation was performed for the finished device product description: lps univ tib hin ins xsm 16mm product code: 198727116 lot number: j3940j and no non-conformances or manufacturing irregularities were identified.

• Brand Name: LPS UNIV TIB HIN INS XSM 16MM
• Common Device Name: LPS AND S-ROM : KNEE TIBIAL INSERT
• 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: 16712061
• Report Number: 1818910-2023-07628
• Device Sequence Number: 7263462
• Product Code: KRO
• UDI-Device Identifier: 10603295079415
• UDI-Public: 10603295079415
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K091453
• 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1987-27-116
• Device Catalogue Number: 198727116
• Device Lot Number: BFI1DPS
• 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: 03/22/2023
• Supplement Date Received by Manufacturer: 05/05/2023; 05/22/2023; 05/30/2023; 06/16/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 05/11/2023; 05/23/2023; 05/30/2023; 06/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2019
• 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