MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE SHOULDER SYSTEM STANDARD TAPER ADAPTOR; EXTREMITIES - IMPLANT

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	09/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient was revised a second time approximately 2 months ago due to disassociation.At that time the baseplate and screws were taken out along with the taper and glenosphere.Attempts have been made and there is no further information at this time.
Additional Manufacturer Narrative
(b)(4).D10 - medical product: catalog #: 115330, comp rvrs shdr glen bsplt +ha, lot # 245740.Catalog #: 180552, comp lk scr 3.5hex 4.75x25 st, lot # 66008638.Catalog #: 180550, comp lk scr 3.5hex 4.75x15 st, lot # 66077441.Catalog #: 180552, comp lk scr 3.5hex 4.75x25 st, lot # 66058947.Catalog #: 180551, comp lk scr 3.5hex 4.75x20 st, lot # 66071785.H3: product has been received by zimmer biomet and the investigation is in process.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: 0001825034-2023-02643.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Updated: b4, b5, d1, d2, d4 (exp date, udi), g3, h1, h2, h3, h4, h6, h10.Reported event was not confirmed as the radiographs could not be read also what was seen by visual examination does not confirm reported issue.Visual examination of the returned product identified the baseplate and the taper show signs of use.The baseplate has scratches and gouges on the non coated side and the taper has scratches and gouges on the post and near the lot number.Radiographs were provided, however, they were not sent to mmi for review by a health care professional.The x-ray is an intraop fluoroscopy image of poor quality and only partial visualization of the shoulder 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: COMPREHENSIVE SHOULDER SYSTEM STANDARD TAPER ADAPTOR
• Common Device Name: EXTREMITIES - 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: 18118674
• Report Number: 0001825034-2023-02646
• Device Sequence Number: 12483798
• Product Code: HSD
• UDI-Device Identifier: 00880304217249
• UDI-Public: (01)00880304217249(17)330717(10)J7569385
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K060716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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
• Report Date (Section B): 03/20/2024

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: 118001
• Device Lot Number: J7569385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2023
• 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: 10/16/2023
• Supplement Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2023
• 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: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male