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

Model Number N/A

Device Problems Unstable (1667); Insufficient Information (3190)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 10/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it is still implanted in the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 13 states, "intraoperative or postoperative bone fracture and/or postoperative pain." multiple mdr reports were filed for this event, please see associated reports: 1825034-2016-03656/ 0001825034-2017-02414/ 0001825034-2017-02416/ 0001825034-2017-02417/ 0001825034-2017-02418/0001825034-2017-02419/0001825034-2017-02421/0001825034-2017-02422/0001825034-2017-02423.

Event Description

It was reported that the patient underwent a right shoulder arthroplasty.Subsequently, approximately twenty-one months post-operatively, the patient reportedly experienced onset of new pain and difficulty with overhead activity/movement.Furthermore, at two year post-operative follow-up, it was reported that the patient had continued pain, acromioclavicular joint tenderness, and a "twinge" sensation after long periods of holding their arms up.No revision has been indicated to date, as the issue is being monitored and outcome is pending.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical product - versa-dial 42x18x26 humeral head, catalog#: 113032, lot#: 620590 ; versa-dial/comprehensive ti standard taper, catalog#: 118001, lot#: 115820; md hybrid glenoid base 4 mm, catalog#: 113954, lot#: 696930; pt hybrid glenoid post regenerex, catalog#: pt-113950, lot#: 052420.Reported event was unable to be confirmed due to limited information received from the customer.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 was reported that the patient underwent a right shoulder arthroplasty.Subsequently, approximately twenty-one months post-operatively, the patient reportedly experienced onset of new pain and difficulty with overhead activity/movement.Furthermore, at two year post-operative follow-up, it was reported that the patient had continued pain, acromioclavicular joint tenderness, anterior apprehension, and a "twinge" sensation after long periods of holding their arms up.No revision has been indicated to date, as the issue is being monitored and outcome is pending.

• Brand Name: COMPREHENSIVE SHOULDER SYSTEM PRIMARY MINI LENGTH SHOULDER 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: 6465117
• MDR Text Key: 71916782
• Report Number: 0001825034-2017-02420
• 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: 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• 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: 113631
• Device Lot Number: 503990
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2014
• 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: 87