MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK RESECTION BLOCK; JRN : RESECTION BLOCKS/DEVICES

Catalog Number UNK RESECTION BLOCK

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Insufficient Information (4580)

Event Date 11/24/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint (b)(4).D4-the device catalog number is unknown; therefore, udi is unavailable.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: silva an, tay ywa, si heng st, foo ssl, pang hn, keng jin dt, lo nn, yeo sj.Ct-based trumatch® personal solutions for knee replacement surgery ¿ does it really match? j orthop.2019 nov 27;19:17-20.Doi: 10.1016/j.Jor.2019.11.040.Pmid: 32021029; pmcid: pmc6994790.Objective and methods: authors studied the effectiveness of depuy ct-based trumatch personal solutions in total knee replacement compared to a matched cohort that received a standard total knee replacement without trumatch.44 total knees were included in the tru-match group, and a matched series of 44 knees with similar demographics and comorbidities were treated with conventional total knee arthroplasties.The authors provided no product information with respect to total knee system(s) manufacturer(s) nor generalities, such as type of bearings, or pressfit vs.Cemented interfaces, etc.Results: follow-up extended over a two-year period.The authors measured the actual measured bone results of the trumatch cutting blocks compared to predicted amounts using conventional x-ray templating.The results varied significantly from predicted values.Additionally, in three instances, the tibia had to be recut freehand, even requiring the use of the tibial external medullary guide in one case (the trumatch cutting block did not correspond to the contours of the patient¿s tibia).Two knees required additional cutting on the femoral side.There were no reported patient consequences reported with respect to these modifications to the procedure, just the acknowledgment that the trumatch blocks did not function as intended.Authors reported that the trumatch blocks provided no statistical benefit with respect to patient recovery, surgical or time, or intra or post operative complications or conventional approaches.None of the patients in either group (trumatch or conventional) experienced a fat embolism.The trumatch group required blood transfusion in five cases, while only a single case of transfusion was required in the conventional group.The trumatch group experienced a single instance of post-op wound infection, while the conventional group experienced two cases (treatment specifics were not provided).Complications: trumatch - plan/guide mismatch to patient anatomy: 5 (3 tibia/2 femur) trumatch - blood transfusion: 5 conventional - blood transfusion: 1 trumatch - wound infection: 1 conventional - wound infection: 2.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.

• Brand Name: UNK RESECTION BLOCK
• Type of Device: JRN : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17690005
• MDR Text Key: 322722023
• Report Number: 1818910-2023-18207
• Device Sequence Number: 1
• Product Code: HTZ
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK RESECTION BLOCK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1