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); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 03/12/2015

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/ 0001825034-2017-02416/ 0001825034-2017-02417/ 0001825034-2017-02418/0001825034-2017-02419/0001825034-2017-02420/0001825034-2017-02421/0001825034-2017-02422/0001825034-2017-02423.

Event Description

It was reported that the patient underwent a right total shoulder arthroplasty.Subsequently, pain and acromioclavicular joint tenderness were noted at three month post-operative follow-up.At one year post-operative follow-up, biceps tendon tenderness, impingement, unusual shoulder pain and pulling sensation around the incision site, and a "puckering in" deformity of the right middle of the shoulder were reported.No revision procedure has been indicated at this time, as the issue remains tolerated.

Manufacturer Narrative

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.X-ray review indicates that progressive glenoid component radiolucency is detected in zones 1, 2, 3, and 4 between the month 3 and month 12 follow-up visits.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.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 total shoulder arthroplasty.Subsequently, pain, instability, and acromioclavicular joint tenderness were noted at three month post-operative follow-up.At one year post-operative follow-up, biceps tendon tenderness, impingement, unusual shoulder pain and pulling sensation around the incision site, and a "puckering in" deformity of the right middle of the shoulder were reported.Instability had resolved.No revision procedure has been indicated at this time, as the issue remains tolerated.

• 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: 6463593
• MDR Text Key: 71886875
• Report Number: 0001825034-2017-02414
• 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: 05/25/2017

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: 05/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2014
• Is the Device Single Use?: No
• 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: 68 YR
• Patient Weight: 87