MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE PRIMARY STEM 12MM MINI; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Ossification (1428); Erythema (1840); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: part: 118001, lot: 470680, comprehensive standard taper adapter.Part: 113053, lot: 550880, comprehensive modular head 50x21x57.Part: 113956, lot: 646490, hybrid glenoid base large 4mm.Part: pt-113950, lot: 286110, porous titanium hybrid glen post regenerex.Customer has indicated that the product will not be returned to zimmer biomet for evaluation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 1825034-2017-01702 / 01704, 01706 and 01708.

Event Description

It was reported that the patient underwent a right total shoulder arthroplasty.Clinical follow-up six weeks post-op, reported patient experienced pain, mild supraspinatus and greater tuberosity tenderness, triceps tenderness, and impingement.Subsequently, erythema was observed at the proximal aspect of the incision thirty-two days post-operatively, and was reported to have resolved after forty-five days.Clinical follow-up three months post-op reported patient experienced instability, ongoing pain, and mild incision tenderness.Clinical follow-up approximately one year post-op reported the patient experienced bicep and deltopectoral tenderness, ongoing pain, and heterotopic ossification formation.There has been no revision reported to date, and no additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action(s) is/are required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided, however, information was received that the patient does heavy lifting at work which may have been a contributing condition.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: COMPREHENSIVE PRIMARY STEM 12MM MINI
• 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: 6414546
• MDR Text Key: 70251017
• Report Number: 0001825034-2017-01702
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK060692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 113632
• Device Lot Number: 493410
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2015
• 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 Outcome(s): Other
• Patient Weight: 115