MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS CNTRL 6.5X30MM ST/RST; PROSTHESIS, SHOULDER

Catalog Number	115396
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	07/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat: 115330 lot: 289590 comp rvrs shdr glen bsplt +ha; cat: xl-115363 lot: 749930 arcom xl 44-36 std hmrl brng ; cat: 118001 lot: 047630 versa-dial/comp ti std taper; cat: 115370 lot: 284530 comp rvs tray co 44mm; unknown glenosphere.G2: foreign- eu: poland.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: 0001825034 - 2023 - 01752.0001825034 - 2023 - 01766.
Event or Problem Description
It was reported that the patient's right shoulder was revised approximately seven months post-initial implantation due to the dislocation of the prosthesis.Intraoperatively, there was loosening of the central screw as well.Attempts to obtain additional information have been made; however, no more is available at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Devices are used for treatment.Reported event was confirmed by review of radiographs.Review of the available records identified the following: initial images demonstrate anatomic alignment of the reverse-type right shoulder arthroplasty complicated by glenosphere disassociation.Updated images demonstrate anatomic alignment.There was malalignment on the images with glenosphere disassociation as noted.No loosening, radiolucency or other abnormality.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01751, 0001825034-2024-00218.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: COMP RVS CNTRL 6.5X30MM ST/RST
• Common Device Name: PROSTHESIS, SHOULDER
• 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: 17427799
• Report Number: 0001825034-2023-01767
• Device Sequence Number: 18072892
• Product Code: KWS
• UDI-Device Identifier: 00880304677081
• UDI-Public: (01)00880304677081(17)320409(10)019180
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K080642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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
• Report Date (Section B): 01/31/2024

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 Catalogue Number: 115396
• Device Lot Number: 019180
• 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: 07/17/2023
• Supplement Date Received by Manufacturer: 01/03/2024; 01/29/2024
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 01/22/2024; 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2022
• 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: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male