MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE SHOULDER TAPER ADAPTER; PROSTHESIS, SHOULDER

Catalog Number 118001

Device Problem Unstable (1667)

Patient Problems Pain (1994); Tissue Damage (2104); Limited Mobility Of The Implanted Joint (2671)

Event Date 08/01/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Udi#- (b)(4).This report is number 2 of 5 mdrs filed for the same patient (reference 1825034-2017-00058/ 00060/00062/ 00064/ 00065).

Event Description

Patient reportedly experienced pain, instability, and tenderness noted approximately six weeks post-implantation.Unusual pain was additionally reported with onset approximately six months post-operatively.Continued pain, instability, tenderness, and impingement were further noted approximately twelve months post-implantation.No revision has been reported to date.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Medical product: comprehensive shoulder system mini humeral stem, catalog#: 113634, lot#: 294510.Comprehensive shoulder system modular head variable offset, catalog#: 113065, lot#: 337270.Hybrid glenoid base, catalog#: 113956, lot#: 193480.Hybrid glenoid porous titanium glenoid post regenerex, catalog#: pt-113950, lot#: 286100.Complaint x-rays were evaluated and the reported event could not be confirmed.The x-ray reviewer stated "left total shoulder arthroplasty components remain intact and appear grossly unremarkable at one year.The cause of the reported events is not clearly indicated on x-rays.Clinical symptoms of pain, instability and impingement may be related to soft tissue factors (example rotator cuff pathology) not apparent on x-rays." 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 is reported that patient began experiencing pain, approximately 6 months post-operatively.At 12 months post-operatively, patient reported pain, instability, immobility, impingement, and tenderness.No revision has been scheduled.Outcome of treatment is pending.

Manufacturer Narrative

(b)(4).

Event Description

It is reported that patient began experiencing pain approximately 6 months post-operatively.At 12 months post-operatively, patient reported pain, instability, immobility, impingement, and tenderness.It was further reported at two (2) year follow-up, that patient is still experiencing pain, tenderness, subacromial crepitus, and limited range of motion.The issues were noted to be tolerated, and no revision or further treatment has been indicated at this time.

• Brand Name: COMPREHENSIVE SHOULDER TAPER ADAPTER
• 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: 6224750
• MDR Text Key: 63950940
• Report Number: 0001825034-2017-00060
• 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: study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 118001
• Device Lot Number: 429980
• Other Device ID Number: REFERENCE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 84