MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE SHOULDER SYSTEM STANDARD TAPER ADAPTOR; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Limited Mobility Of The Implanted Joint (2671)

Event Date 02/23/2017

Event Type  Injury  

Manufacturer Narrative

Cmp(b)(4).(b)(4).Medical products-comprehensive primary stem catalog#: 113630 lot#: 271410 hybrid glenoid post catalog#: pt-113950, lot#: 682230, humeral head catalog#:113042 lot#:651410, glenoid base catalog#:113954 lot#:333950.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted in thepatient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-02385/0001825034-2017-02401, 0001825034-2017-03101, 0001825034-2017-03105.

Event Description

It is reported that the patient underwent right total shoulder arthroplasty.Subsequently, pain, supraspinatus tenderness, acromioclavicular tenderness, biceps tenderness, forearm tenderness, and impingement were noted at six (6) week post-operative follow-up.Continued pain, instability, impingement, and incision tenderness were noted at three (3) month post-operative follow-up.One (1) year post-operative follow-up noted pain, supraspinatus/greater tuberosity tenderness, acromioclavicular tenderness, biceps tendon tenderness, impingement, and difficulty with internal rotation were noted.No revision procedure has been indicated, as the condition is noted to be tolerated at this time.

Manufacturer Narrative

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.

• Brand Name: COMPREHENSIVE SHOULDER SYSTEM STANDARD TAPER ADAPTOR
• 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: 6545805
• MDR Text Key: 74446191
• Report Number: 0001825034-2017-03104
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK060716
• 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: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• 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: 118001
• Device Lot Number: 085220
• Other Device ID Number: REFERENCE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2016
• 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: 95