MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE SHOULDER SYSTEM MINI HUMERAL STEM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Ossification (1428); Pain (1994)

Event Date 01/31/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Current information is insufficient to permit a conclusion as to the cause of the event.Multiple mdr reports were filed for this event; please see associated reports: 0001825034-2017-02191.The following could not be completed with the limited information provided.Date explanted - ni, medical product - versa-dial comprehensive taper catalog #: 118001 lot #: 053000, sm hybrid glenoid base catalog #: 113952 lot #: 650170, pt hybrid glenosphere post regenerex catalog #: pt-113950 lot #: 970050, comprehensive shoulder modular head catalog #: 113044 lot #: 698230.(b)(4).

Event Description

It is reported that the patient underwent a total shoulder arthroplasty.Subsequently, the patient developed right wrist and forearm pain one day post-operatively that reportedly resolved three days post-operatively without medical intervention.Pain, instability, moderate acromioclavicular joint tenderness, biceps tendon tenderness, and supraspinatus/greater tuberosity tenderness were noted at six week post-operative follow-up.Continued pain, instability, and mild biceps tendon tenderness were noted at three month post-operative follow-up.Lastly, post-operative radiographs noted heterotopic ossification formation around the humeral shaft approximately fifteen months post-implantation.The surgeon does not plan to revise the patient at this time, as the issue is reported to be tolerated.No further information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of x-rays provided.X-ray review revealed glenoid, radiolucency as follows: 6 weeks: glenoid radiolucency in zones 1, 2, 3, 4, 5, 8; central peg radiolucency; z3: 0.5 mm; z4:0.5 mm; z6: 0.4 mm, 3 month: glenoid radiolucency in zones 1, 2, 3, 4, 5, 8; central peg radiolucency:; z2: 0.4 mm; z3: 0.5 mm; z4: 0.5 mm; z5: 0.3 mm, 1 year: glenoid radiolucency in zones 1, 2, 3, 4; central peg radiolucency; zone 3: 0.5 mm; zone 4: 0.5 mm; zone 5: 0.5 mm; zone 6: 0.4 mm.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event 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.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.

Event Description

It is reported that the patient underwent a total shoulder arthroplasty.Subsequently, the patient developed right wrist and forearm pain one day post-operatively that reportedly resolved three days post-operatively without medical intervention.Pain, instability, moderate acromioclavicular joint tenderness, biceps tendon tenderness, and supraspinatus/greater tuberosity tenderness were noted at six week post-operative follow-up.Continued pain, instability, and mild biceps tendon tenderness were noted at three month post-operative follow-up.Lastly, post-operative radiographs noted heterotopic ossification formation around the humeral shaft approximately fifteen months post-implantation and radiolucency around the glenoid components from six (6) weeks and continuing into (1) year post-operatively.The surgeon does not plan to revise the patient at this time, as the issue is reported to be tolerated.No further information is available.

• Brand Name: COMPREHENSIVE SHOULDER SYSTEM MINI HUMERAL 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: 6455027
• MDR Text Key: 71552386
• Report Number: 0001825034-2017-02193
• 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
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• 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: 113633
• Device Lot Number: 000420
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2015
• 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 Age: 62 YR
• Patient Weight: 131