MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK KNEE FEMORAL HINGE PIN LPS

Catalog Number UNK KNEE FEMORAL HINGE PIN LPS

Device Problem Off-Label Use (1494)

Patient Problems Joint Laxity (4526); Unspecified Tissue Injury (4559)

Event Date 05/18/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.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.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

It was reported that the patient had undergone a quadriceps reconstruction at here previous surgery and the graft stretched out leaving a very lax quadriceps mechanism.The surgeon chose to place a thicker insert address the stretching on the tibial side and help place the joint line in a more appropriate position based upon the now stitched patellar ligament.He refashioned the proximal portion of the graft and overlaid the graft with an allograft facia lata to reinforce the construct.No instruments were broken, no patient harm occurred and the same pin was used from the distal femoral component.Doi: (b)(6) 2023.Dor: (b)(6) 2023.Affected side : left knee.

• Brand Name: UNK KNEE FEMORAL HINGE PIN LPS
• Type of Device: UNK KNEE FEMORAL HINGE PIN LPS
• 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: 17031271
• MDR Text Key: 316280365
• Report Number: 1818910-2023-11213
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/31/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE FEMORAL HINGE PIN LPS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2023
• Initial Date FDA Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: ATTUNE REV LPS INSRT XXSM 12MM; LPS DISTAL FEM COMP XXSM LT
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female