MAUDE Adverse Event Report: BIOMET ORTHOPEDICS PT HYBRID GLEN POST REGENEREX; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Necrosis (1971); Pain (1994); Tissue Damage (2104); Post Operative Wound Infection (2446)

Event Date 06/21/2015

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: the patient is to be made aware in advance of surgery and warned of general surgical risks, possible adverse effects as listed, and to follow the instructions of the treating physician, including follow-up visits.This report is number 4 of 4 mdr's filed for the same event (reference 1825034-2017-01258 / 01261).

Event Description

It was reported that patient is experiencing possible late subscalpularis failure 18 months post-implantation of right shoulder arthroplasty.No revision procedure has been reported to date.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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 was reported that a patient underwent a right total shoulder arthroplasty.Subsequently, the patient experienced unknown wound problems (dehiscence, necrosis, drainage, or superficial infection) thirty-eight days post-operatively.This was reported to be not device related, however related to the procedure, and reportedly resolved.At three month post-operative follow-up, instability was observed, however the patient was reportedly satisfied and had no issues.At the one year post-operative follow-up, instability was again observed and moderate pain was noted, however the patient still reported that they were satisfied and had no issues related to the shoulder.Lastly, possible late subscalpularis failure was reported at eighteen months post-implantation.Outcome of treatment is pending.No revision procedure has been reported to date.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical product: versa-dial shoulder modular head, catalog#: 113032, lot#: 101610; comprehensive shoulder taper adaptor, catalog#: 118001, lot#: 465310; hybrid glenoid base, catalog#: 113952, lot#: 856280.Event was confirmed by review of provided x-rays.Anterior subluxation of the humerus confirms the reported event of subscapularis failure.Radiolucency indicates possible glenoid loosening.An ossification projects over the axillary pouch on the ap view, possible lesser tuberosity avulsion bone fracture fragment.Review of the complaint history determined that no further action(s) is/are required.Root cause remains undetermined.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Root cause remains undetermined.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 was reported that a patient underwent a right total shoulder arthroplasty.At three month post-operative follow-up, instability was observed, however the patient was reportedly satisfied and had no issues.At the one year post-operative follow-up, instability was again observed and moderate pain was noted, however the patient still reported that they were satisfied and had no issues related to the shoulder.Lastly, possible late subscalpularis failure was reported at eighteen months post-implantation.Outcome of treatment is pending.No revision procedure has been reported to date.

• Brand Name: PT HYBRID GLEN POST REGENEREX
• 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: 6371450
• MDR Text Key: 68756066
• Report Number: 0001825034-2017-01261
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK060694
• 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,Followup
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: PT-113950
• Device Lot Number: 019700
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2014
• 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: 69 YR
• Patient Weight: 79