MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVSR SHLDR GLNSP +3 36MM; EXTREMITIES IMPLANTS

Model Number	N/A
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Bacterial Infection (1735); Failure of Implant (1924); Foreign Body In Patient (2687)
Date of Event	04/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had an initial surgery approximately 3 years ago, subsequently the patient had a revision for the removal of the glenosphere implant, during the surgery a fractured screw was partially removed; however, some of the screw remained in the glenoid.Also, the bacteriology was positive for cuti acnes, but no intraoperative septic signs, nor pain before the breakage of the material.Attempts have been made and there is no further information at this time.
Additional Manufacturer Narrative
(b)(4).Concomitant medical product: catalog #: 110032430, comp aug mini bsplt w tpr lg, lot # unknown; catalog #: unknown, screw, lot # unknown.Report source: france.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: 0001825034-2023-00453, 0001825034-2023-00455.
Additional Manufacturer Narrative
Cmp-0865395 medical product: catalog #: 110032430, comp aug mini bsplt w tpr lg, lot # 64836356 catalog #: 180561, comp nlk scr 3.5hex 4.75x35 st, lot # 093390 catalog #: 180560, comp nlk scr 3.5hex 4.75x30 st, lot # 380220 catalog #: 180559, comp nlk scr 3.5hex 4.75x25 st, lot # 376920 catalog #: 00434903603, 36mm ã¿ +3mm offset poly line, lot # 64687488 catalog #: 00434901413, 14mm ã¿ 130mm length humeral stem, lot # 64759385 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-00453, 0001825034-2023-00455, 0001825034-2023-00756, 0001825034-2023-00757.
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.Reported event was confirmed as visual examination of the provided photos show the screws holding the baseplate had broken.Further examination was not completed as the products were not returned.Medical records/radiographs identified the following: significant findings include three separate fracture screw fragments within the glenoid with bone erosion along the glenoid could represent evidence of patient infection.Overall fit and alignment of implants on post-op images is appropriate.Mild osteopenia is present.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not be determined for the fractured screws.The root cause of the infection was determined to be unrelated to the implanted zimmer biomet device.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 had an initial surgery approximately 3 years ago, subsequently they then had a revision for the removal of the glenosphere implant and baseplate pullout.During the revision there was a broken screw that was partially removed, however some the screw remained in the glenoid.Also, the bacteriology was positive for cuti acnes, but there were no intraoperative septic signs, nor pain before the breakage of the material.Attempts have been made and there is no further information at this time.

• Brand Name: COMP RVSR SHLDR GLNSP +3 36MM
• Common Device Name: EXTREMITIES IMPLANTS
• 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: 16486644
• Report Number: 0001825034-2023-00454
• Device Sequence Number: 20308224
• Product Code: KWS
• UDI-Device Identifier: 00880304475779
• UDI-Public: (01)00880304475779(17)300326(10)245030
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K080642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/18/2023

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: 115313
• Device Lot Number: 245030
• 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: 02/23/2023
• Supplement Date Received by Manufacturer: 03/17/2023; 08/16/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 04/05/2023; 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown