MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL 46X21X50 HUM HEAD; PROSTHESIS, SHOULDER

Catalog Number 113044

Device Problems Material Erosion (1214); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problems Failure of Implant (1924); Pain (1994); Synovitis (2094); Osteolysis (2377); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

Event Date 02/25/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-00972.Concomitant medical products: item# 113952; lot# 010150, item# 118001; lot# 859480, item# 113632; lot# 571370, item# pt-113950; lot# 360780, item# 402439; lot# 700610.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 was revised approximately eight (8) years post-implantation due to poly wear of the baseplate, causing metal-on-metal contact between the baseplate and humeral head.Subsequently, the patient experienced pain, bone loss from the metal debris, and synovitis as a result of the event.Attempts have been made and no further information has been provided.

Event Description

It was reported a patient underwent a revision with synovectomy approximately eight (8) years post-implantation due to metallosis, ongoing pain, synovitis, bone loss, and displaced and worn polyethylene component.A spacer was implanted while the patient awaits a patient made implant.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The investigation is still in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6: component code - mechanical (g04) - head.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: on an unknown date during scoping, extensive metal oasis of synovium, worn out polyethylene, and cultures negative noted.Extensive synovitis, stained black, underneath the head with some bone loss around the stem.The stem remained well fixed.Minimal scratches to humeral head without gouges.Displaced polyethylene component and once removed, massive bone loss noted on the posterior aspect.Exposure to the glenoid revealed some metalization to the level of the coracoid and a shell of bone anterioraly.Bloodwork to be checked for metal ions and tissue found in healthy condition.Metal components removed and cement spacer implanted while custom prosthesis is being made.Cultures pending.No intra-op complications/events.Synovial pathology results include: fibroconnective tissue with chronic inflammation and abundant pigment deposition.No significant acute inflammation present.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: VERSA-DIAL 46X21X50 HUM HEAD
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14206653
• MDR Text Key: 290059520
• Report Number: 0001825034-2022-00969
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2023
• Device Catalogue Number: 113044
• Device Lot Number: 524560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2013
• 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): Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male