MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN COMPREHENSIVE SHOULDER IMPLANT; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Pain (1994); Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Halverson et al.(2016) "plication of the posterior capsule for intraoperative posterior instability during anatomic total shoulder arthroplasty" journal of shoulder and elbow surgery.The reported event was unable to be confirmed due to limited information received from the customer.A device history record review was unable to be performed as the lot number of the device involved in the event is unknown.A complaint history review was unable to be performed as the part and lot numbers are unknown.A root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.The article was written by eduard alentorn-geli, andrew t.Assenmacher, john w.Sperling, robert h.Cofield and joaquín sánchez-sotelo.The complaint device is not expected for return currently, but a supplemental medwatch 3500a will be submitted upon receipt of additional information.

Event Description

It is reported in a journal article that one patient underwent a reoperation due to posterior capsule plication failure, followed by pain, rotator cuff failure and instability following shoulder arthroplasty.The patient underwent a rotator cuff repair along with a revision to a larger humeral head, however the patient still experienced poor function but had a stable shoulder.Attempts have been made to obtain additional information and further information is not available at this time.

• Brand Name: UNKNOWN COMPREHENSIVE SHOULDER IMPLANT
• 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: 6632000
• MDR Text Key: 77274405
• Report Number: 0001825034-2017-03715
• Device Sequence Number: 1
• Product Code: MJT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/12/2017
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention