MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS CNTRL 6.5X35MM ST/RST; FASTENER, FIXATION

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: catalog #: 110027734, compr vrs glen pps min tpr adr, lot # 108100, catalog #: 180552, comp lk scr 3.5hex 4.75x25 st, lot # 445710, catalog #: 180553, comp lk scr 3.5hex 4.75x30 st, lot # 142380, catalog #: 180551, comp lk scr 3.5hex 4.75x20 st, lot # 139860, catalog #: 180553, comp lk scr 3.5hex 4.75x30 st, lot # 344150, catalog #: 110031178, comp vrs bone and imp mdl, lot # 716940, catalog #: 110027734, compr vrs glen pps min tpr adr, lot # 276730, catalog #: 110031378, versa-dial taper adaptor 25mm, lot # 276760.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: 0001825034-2019-05176, 0001825034-2020-01106, 0001825034-2020-01107, 0001825034-2020-01108, 0001825034-2020-01109, 0001825034-2020-01110.Unknown if the product will be returned.
Event or Problem Description
It was reported that the patient underwent an initial right shoulder arthroplasty on an unknown date.Subsequently, the patient plans to be revised due implant loosening.However, no revision procedure has been reported to date.
Additional Manufacturer Narrative
(b)(4).Reported event was considered confirmed as the x-rays showed that there was displacement of the glenosphere from the glenoid resulting in dislocation.Device history record was reviewed and no discrepancies relevant to the reported event 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.
Event or Problem Description
It was reported that the patient underwent an initial left should arthroplasty.Subsequently, underwent a revision due to loosening of the implant.The x-ray provided shows dislocation of the shoulder.No additional information is available.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(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.

• Brand Name: COMP RVS CNTRL 6.5X35MM ST/RST
• Common Device Name: FASTENER, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9835935
• Report Number: 0001825034-2020-01110
• Device Sequence Number: 2204952
• Product Code: KWS
• UDI-Device Identifier: 00880304677098
• UDI-Public: (01)00880304677098
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K132239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2021

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: 115397
• Device Lot Number: 991880
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 03/24/2020; 09/28/2021
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 03/30/2020; 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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 Age: 72 YR