MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL 46X18X53 HUM HEAD; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED

Catalog Number	113042
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Inflammation (1932); Damage to Ligament(s) (1952)
Date of Event	11/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports:0001825034-2021-03417,0001825034-2021-03418.Comcomitant medical products: item# 113954; lot# 996800, item# pt-113950; lot# 241890, item# 118001; lot# 256620, item# 115330; lot# 734280, item# 405889; lot# 321360, item# 405883; lot# 291840, item# 405800; lot# 579190, item# 115395; lot# 346230, item# 180554; lot# 705840, item# 180550; lot# 464210, item# 180552; lot# 697300, item# 180550; lot# 787440, item# 118001; lot# 386740, item# 115310; lot# 244620, item# 110031424; lot# 64980771, item# 110031399; lot# 65142051, item# 110004347; lot# 770440, item# 115736; lot# 866520r, item# 20-8000-000-11; lot# 63706262.Report source:foreign - event occurred in (b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was requested but not returned by the hospital.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 or Problem Description
It was reported that the patient underwent a revision surgery approximately four (4) years and one (1) month post-implantation due to rotator cuff failure and loose glenoid component.Surgeon stated that at the time of the primary implantation, the patient had undiagnosed inflammatory arthropathy.Attempts have been made and no further information has been provided.
Event or Problem Description
No additional information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The reported event was confirmed by review of the provided medical records.Radiographs identified moderate-sized periprosthetic lucency surrounding glenoid screw, consistent with loosening and/or infection.Aside from the lucency, remaining bone quality is normal.Review of the device history records identified no deviations or anomalies during manufacturing related to the event.A definitive root cause could not be determined.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: VERSA-DIAL 46X18X53 HUM HEAD
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED
• 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: 13624682
• Report Number: 0001825034-2022-00372
• Device Sequence Number: 20115051
• Product Code: MBF
• UDI-Device Identifier: 00880304212220
• UDI-Public: (01)00880304212220(17)270808(10)594640
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K193038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2022

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 113042
• Device Lot Number: 594640
• 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: 11/30/2021
• Supplement Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 02/28/2022
• Supplement Report FDA Received Date: 03/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 75 KG