MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GLENOSPHERE 36 MM DIAMETER; PROSTHESIS, SHOULDER

Model Number	N/A
Medical Device Problem Codes	Material Erosion (1214); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Metal Related Pathology (4530)
Date of Event	10/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: unknown tm baseplate: 0104223363, 2944588 anatomical shoulderâ reverse, humeral insert, pe, 36-3.Unk glenoshpere head.Foreign country: (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-03102.
Event or Problem Description
It was reported patient underwent initial shoulder arthroplasty on unknown date.Subsequently, the patient was revised due to disassociation.It was reported the glenosphere had detached from the tm base plate.The glenosphere and pe inlay were removed and replaced.During the revision, metallosis was present in the joint.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: a1; a4; b7; d6.
Event or Problem Description
No further event information available at the time of this report.
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.The following sections were updated/corrected.Reported event was unable to be confirmed due to limited information received from the customer.Medical records from the initial operative report were provided and reviewed by a health care professional.Review of the available records identified an unknown plate and screws were removed, 1 screw had migrated and was removed.Reverse tsa cemented into place without complications.Medical records were not provided for the revision surgery.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.A2: year of birth: 1939.
Event or Problem Description
It was reported patient underwent initial reverse total shoulder arthroplasty performed.Subsequently, the patient underwent revision of the glenosphere and poly insert approximately 6 months post implantation due to pain, limited mobility, and metallosis secondary to disassociation of the glenosphere from the baseplate.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: remove type of investigation code 4114 ¿ device not returned.Visual examination of the returned product identified damage in the form of nicks and scratches on the outer spherical surface.No damage was found to the taper of the glenosphere.The taper diameter and angle were inspected at the time of manufacture and all devices were conforming to print specification.The additional information does not change the outcome of the previous investigation.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
No additional event information to report at this time.

• Brand Name: GLENOSPHERE 36 MM DIAMETER
• Common Device Name: PROSTHESIS, SHOULDER
• 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: 12693474
• Report Number: 0001822565-2021-03101
• Device Sequence Number: 4550085
• Product Code: KWS
• UDI-Device Identifier: 00889024269088
• UDI-Public: (01)00889024269088(17)310118(10)64973219
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K130661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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,Followup,Followup,Followup
• Report Date (Section B): 04/05/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00434903611
• Device Lot Number: 64973219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/13/2021
• Supplement Date Received by Manufacturer: 10/30/2021; 02/07/2022; 02/24/2022; 04/04/2022
• Initial Report FDA Received Date: 10/25/2021
• Supplement Report FDA Received Date: 11/01/2021; 02/17/2022; 03/03/2022; 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2021
• 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 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 74 KG