MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL 50X21X57 HUM HEAD; PROSTHESIS, EXTREMITY

Model Number N/A

Device Problems Unintended System Motion (1430); Unstable (1667); Noise, Audible (3273)

Patient Problems Muscle Spasm(s) (1966); Muscle Weakness (1967); Pain (1994); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: us-115740 humeral component, lot 115220, 118001 taper adaptor, lot 381590, 113053 humeral head, lot 101640, 113956 glenoid base, lot 468830, pt-113950 regenerex peg, lot 304740.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 - 2018 - 08879, 0001825034 - 2018 - 08880, 0001825034 - 2018 - 08881.Still implanted.

Event Description

It was reported patient underwent a right total shoulder arthroplasty.Subsequently, the patient experienced a popping sensation/noise in the operative shoulder, beginning approximately three (3) months post-operatively.Numbness, tenderness, and muscle fatigue/spasms in the operative arm were further reported at two (2) year follow-up.Pain with crepitus, instability, and impingement have been reported as ongoing.The patient has not been revised and is monitored within the study.No further information is available.

Event Description

No further information is available.

Manufacturer Narrative

His follow-up report is being submitted to relay additional information.Reported event was confirmed with patient medical records.No device was returned.Dhr was reviewed and no discrepancies were found.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.(b)(4).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

No further information is available.

• Brand Name: VERSA-DIAL 50X21X57 HUM HEAD
• Type of Device: PROSTHESIS, EXTREMITY
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7938094
• MDR Text Key: 122816027
• Report Number: 0001825034-2018-08878
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: PK060716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 113053
• Device Lot Number: 101640
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 136