MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE SRS MODULAR REGENEREX AUGMENT; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Nerve Damage (1979)

Event Date 01/05/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).Medical product - unknown biomet comprehensive srs proximal body, cat# ni lot#: ni, unknown biomet comprehensive srs distal stem, cat# ni lot#: ni, unknown biomet comprehensive srs humeral tray, cat# ni lot#: ni, unknown biomet comprehensive srs glenosphere, cat# ni lot#: ni, unknown biomet comprehensive srs baseplate, cat# ni lot#: ni.Product is currently not expected to return to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up medwatch will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-05664, 0001825034-2017-05694, 0001825034-2017-05695, 0001825034-2017-05697 and 0001825034-2017-05698.

Event Description

It was reported that a patient that underwent a shoulder arthroplasty experienced palsy of the radial nerve.This was reported to be not a product problem.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Medical products: ep-115398 e1 humeral bearing lot # 410710; ti-115323 comprehensive versadial glenosphere 41mm +3 ti lot # 473880 ; 118001 versa dial/comprehensive standard taper lot # 894650 ; 115370 comprehensive reverse tray lot # 115370 ; 115330 comprehensive reverse glenoid baseplate lot # 229490; 3011630001 refobacin bone cement 1x40g lot # a618cf1307 ; 180550 comprehensive locking screw lot # 061410 ; 180553 comprehensive locking screwlot # 233510; 115396 comprehensive reverse central screw lot # 871810; 180554 comprehensive locking screw lot # 233530 ; 180553 comprehensive locking screw lot # 962420; 211229 comprehensive srs modular regenerex augment lot# 154420; 211225 comprehensive srs ic segment lot# 258170; 211263 comprehensive srs modular stem lot# 885220; 211219 comprehensive srs proximal body lot # 566120.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required as no were trends identified.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 SRS MODULAR REGENEREX AUGMENT
• 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: 6762930
• MDR Text Key: 81718984
• Report Number: 0001825034-2017-05696
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: PK111746
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/28/2024
• Device Model Number: N/A
• Device Catalogue Number: 211228
• Device Lot Number: 311020
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2014
• 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: 70 YR
• Patient Weight: 85