MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL/COMP TI STD TAPER; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	118001
Medical Device Problem Codes	Unstable (1667); Noise, Audible (3273)
Health Effect - Clinical Codes	Arthritis (1723); Failure of Implant (1924); Pain (1994); Subluxation (4525); Joint Laxity (4526); Muscle/Tendon Damage (4532)
Date of Event	12/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient underwent a left shoulder revision approximately four(4) years post implantation due to posterior instability, pain and noise.During the revision the left shoulder was found to have degenerative joint disease, rotator cuff arthropathy, an irreparable rotator cuff tear, and sub luxation of humeral head.All components, except the humeral stem, were removed and replaced with zimmer biomet product.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Zimmer biomet will continue to monitor for trends.Associated products and reports: 0001825034-2023-00168 item#pt-113950; lot#960770.0001825034-2023-00169 item#113048; lot#572420.0001825034-2023-00172 item#113952; lot#539300.Other associated products: item#113653; lot#987670, item#110008096; lot#934310, item#110005307; lot#299460, item#405669; lot#127800, item#110003484; lot#336600, item#110005306; lot#614850.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records and radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: abnormal alignment (posterior subluxation) of the humeral head with respect to the glenoid.There is suggestion that this could be present on the frontal view as there is possible slightly increased spacing of the glenonhumeral joint without overlapping of the humerus with the acetabulum; however, this can also be technical in nature.Overall fit and bone quality likely normal with exception of periprosthetic lucency surrounding the glenoid screw.The screw may be slightly subluxed deep to the articular surface of the glenoid.No instability found besides the abnormal alignment which could cause the hardware to come into contact and cause noise.Evaluation of rotator cuff arthropathy and rotator cuff tear cannot be performed radiographically; only by mri or ct arthrogram can this be done.In a situation of a massive full thickness rotator cuff tear, there is often loss of the subacromial space; however, this is not seen on this radiograph.Assessment for degenerative joint disease is not an assessment to be made with an arthroplasty, as the joint space has been replaced by hardware.Dhr was reviewed and no discrepancies relevant to the reported event were found.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/COMP TI STD TAPER
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16270794
• Report Number: 0001825034-2023-00170
• Device Sequence Number: 20721490
• Product Code: MBF
• UDI-Device Identifier: 00880304217249
• UDI-Public: (01)00880304217249(17)281025(10)057540
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K060716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 118001
• Device Lot Number: 057540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2023
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 97 KG
• Patient Ethnicity: Hispanic