MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL 42X18X46 HUM HEAD; EXTREMITY IMPLANT

Model Number	N/A
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Cyst(s) (1800); Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Osteolysis (2377); Subluxation (4525); Metal Related Pathology (4530)
Date of Event	11/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - medical product: catalog #: pt-113950, pt hybrid glen post regenerex, lot # 819030, catalog #: 113609, comp primary stem 9mm micro, lot # 597750, catalog #: 113952, sm hybrid glenoid base 4mm, lot # 241510, catalog #: 118001, versa-dial/comp ti std taper, lot # 076870.H3: the customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-04041, 0001825034-2021-00899, 0001825034-2023-01293 h3 other text : unknown if product will be returned.
Event or Problem Description
It was reported that an initial left total shoulder arthroplasty was performed approximately 3 years ago.Subsequently, the patient reported to her surgeon that she had been doing fine until she reached down to grab something and felt a pain in her left shoulder.Follow up radiology confirmed fracture of the central screw with subsequent loosening and osteolysis from debris generation.The patient reports she has since had pain, difficulty with activities of daily living, and limited range of motion.The patient was revised to a reverse total shoulder approximately a year and a half ago due to glenoid implant fracture.During the revision, evidence of metallosis and wear were found as well as cystic defects and significant scar tissue.All components were removed and replaced with unknown product except for specifying implantation of a biomet base plate.No further information is available at this time and the study is now complete.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Proposed annex g code: mechanical (g04) - head.The reported event is confirmed through medical records and mmi review.Review of the available records identified the following: fractured glenoid component (porous metal glenoid post).Revision to reverse total shoulder involving both humeral and glenoid components completed, all study components removed.There was a lot of scarring and obliteration of the tissue planes from the previous surgery.There was metallosis with dark staining of all the soft tissues and synovium from metal-on metal wear.The glenoid component polyethylene face was loose.There was a cystic reaction around the inferior glenoid with a lot of blackened metal wear debris, the joint was meticulously debrided of this.She did have a cystic contained defect from the previous peg holes as well as a large cystic reaction of the inferior glenoid that measured 1.5cm.New definitive components were implanted and excellent stability was achieved.Patient to recovery in good condition with no intra-op complications noted.Review of the radiographs found the following: suspected loosening, and mild osteopenia, glenoid implant appears fractured as well as humeral implant appears larger than expected for patients anatomy.Device history record was reviewed and no discrepancies relevant to the reported event were found.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 42X18X46 HUM HEAD
• Common Device Name: EXTREMITY IMPLANT
• 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: 17081281
• Report Number: 0001825034-2023-01294
• Device Sequence Number: 6273745
• Product Code: HSD
• UDI-Device Identifier: 00880304212206
• UDI-Public: (01)00880304212206(17)261218(10)437230
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K060716
• 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: Study,Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2023

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 Model Number: N/A
• Device Catalogue Number: 113032
• Device Lot Number: 437230
• 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: 05/12/2023
• Supplement Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2016
• 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: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 43 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White