MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE SEGMENTAL REVISION SYSTEM 9MMX75MM MODULAR STEM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2016

Event Type  malfunction  

Manufacturer Narrative

Review of device history records show the lot released with no recorded anomaly.(b)(4).Review of manufacturing history found no evidence of product non-conformance.However, inspection of the photo provided in the complaint and review of the surgical technique and the print confirm that the l and r are etched in the incorrect positions.As this issue appears to be localized to this lot, the root cause is likely an operator error.Investigation into this issue is ongoing and when additional information is received, a follow-up report will be submitted to the fda.

Event Description

It was reported that during a total shoulder procedure, the printed l and r on the modular stem were in the incorrect spots and were reversed.The surgeon caught the issue and was able to reassemble the implant into the correct position and the procedure was completed with that stem.

• Brand Name: COMPREHENSIVE SEGMENTAL REVISION SYSTEM 9MMX75MM MODULAR STEM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6156043
• MDR Text Key: 61868372
• Report Number: 0001825034-2016-05133
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: PK111746
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 211258
• Device Lot Number: 142590
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 85 YR