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

Device Problem Fracture (1260)

Patient Problems Calcium Deposits/Calcification (1758); Pain (1994); Joint Laxity (4526)

Event Date 03/17/2023

Event Type  Injury  

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 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 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.

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.

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.

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.

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
• Type of Device: 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
• MDR Text Key: 313006850
• Report Number: 1818910-2023-07628
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 10603295079415
• UDI-Public: 10603295079415
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K091453
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 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
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 110 KG