MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVRS SHDR GLEN BSPLT +HA; EXTREMITY IMPLANT

Model Number	N/A
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	04/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This was previously reported under 0001822565-2024-01744.D10 - medical product: catalog #: 180560, comp nlkscr 3.5hex 4.75x30 st, lot #: 976370.Catalog #: 180560, comp nlk scr 3.5hex 4.75x30 st, lot #: 979490.Catalog #: 180555, comp lk scr 3.5hex 4.75x40 st, lot #: 017930.Catalog #: 115396, comp rvs cntrl 6.5x30mm st/rst, lot #: 017690.Catalog #: 180552, comp lk scr 3.5hex 4.75x25 st, lot #: 533810.Catalog #: 00434904006, 40mm ã¿ +6mm offset poly liner, lot #: 62438566.Catalog #: 110030776, standard offset 40mm diameter glenosphere, lot #: 65026824.G2: australia.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was requested but not returned to the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient was revised due to loss of fixation due to bone graft resorption, screw breakage, instability, and pain.The glenosphere and baseplate were removed and replaced.Attempts have been made and there is no further information at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Updated: b4, b5, d2, d4 (exp date, udi), g3, h1, h2, h3, h6, h11.Reported event was confirmed as visual examination of the provided pictures identified the screws, baseplate, taper, glenosphere, and bearing have been explanted and are covered in biodebris.Two peripheral screws and one central screw have fractured.The liner appears to have abnormal wear as a result of the loosening, but it cannot be confirmed due to the biodebris remnants on the articulating surface.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: two views left shoulder demonstrate a reverse total shoulder arthroplasty with fractured glenosphere screws with glenosphere directed superiorly.Glenohumeral dislocation.No bony fracture seen.Sizing is appropriate.Bony resorption of the glenoid is suspected but poorly seen and may have contributed to this failure.Device history record was reviewed and no discrepancies relevant to the reported event were found.It was reported that the surgeon elected to use a bone graft during the initial procedure and the bone graft resorbed; therefore, the bone graft is a possible contributing factor to the reported issue.However, with the information available a definitive root cause cannot 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: COMP RVRS SHDR GLEN BSPLT +HA
• 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: 19606535
• Report Number: 0001825034-2024-01677
• Device Sequence Number: 17725909
• Product Code: KWS
• UDI-Device Identifier: 00880304475342
• UDI-Public: (01)00880304475342(17)291113(10)247470
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K080642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• 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): 10/31/2024

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: 115330
• Device Lot Number: 247470
• 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: 05/29/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2019
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male