MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BASE PLATE 25 MM POST LENGTH +2 MM LATERAL OFFSET UNCEMENTED; EXTREMITIES, IMPLANT

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Patient's year of birth: (b)(6).Concomitant medical devices: item# 0104223042; lot# 2967413; anatomical shoulderâ¿¢ reverse, screw system, 4.5-42; item# 0104223036; lot# 2975326; anatomical shoulderâ¿¢ reverse, screw system, 4.5-36; item# 00434903611; lot# 64107257; glenosphere 36 mm diameter; item# 00434900813; lot# 63202642; humeral stem 8 mm stem diameter 130 mm stem length; item# 00434903600; lot# 63761005; poly liner plus 0 mm offset 36 mm diameter; item# 66017747; lot# 90624788; palacos cement.Foreign: event occurred in (b)(6).The product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Remains implanted.
Event or Problem Description
It was reported that the patient underwent a reverse shoulder arthroplasty.Subsequently, the patient is being considered for a revision due to loosening of the baseplate.Attempts have been made and additional information on the reported event is unavailable at this time.No additional patient consequences were reported.
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.H3 other text : product not returned.
Event or Problem Description
It was reported that the patient underwent an initial procedure on an unknown date.Subsequently, the patient was revised due to loosening of the baseplate.Heterotopic ossification and anteversion of the glenoid component were also reported.Attempts have been made and additional information on the reported event is unavailable at this time.No additional patient consequences were reported.
Event or Problem Description
It was reported patient underwent a revision procedure 14 months post implantation due to loosening of the baseplate.Heterotopic ossification and anteversion of the glenoid component were also reported.Attempts have been made and additional information on the reported event is unavailable at this time.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: implants were well positioned post procedure with radiolucency noted around the screws.The implant position remain unchanged in the weeks following the procedure with no loosening or fracture of implant or bone.Heterotropic ossification was noted approximately 6 months post procedure.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.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: BASE PLATE 25 MM POST LENGTH +2 MM LATERAL OFFSET UNCEMENTED
• Common Device Name: EXTREMITIES, IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11462711
• Report Number: 0001822565-2021-00515
• Device Sequence Number: 19740888
• Product Code: HSD
• UDI-Device Identifier: 00889024269033
• UDI-Public: (01)00889024269033(17)290331(10)64290315
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K130661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/03/2021

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: 00434902502
• Device Lot Number: 64290315
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 04/14/2021; 08/03/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 05/10/2021; 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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; Other; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 95