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 Codes	Failure of Implant (1924); Pain (1994)
Date of Event	04/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: item#00434903611; lot# 64367752; glenosphere 36 mm diameter.Item# 0104223042; lot# 2985867; anatomical shoulder reverse, screw system, 4.5-42.Item# 0104223036; lot# 3006651; anatomical shoulder reverse, screw system, 4.5-36.Foreign: event occurred in (b)(6).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.
Event or Problem Description
It was reported that patient underwent a revision surgery due to loosening of the tm glenoid baseplate with screw fracture.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 following sections were updated/corrected: a1; b4; b5; b7; g3; g6; h1; h2; h6.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: 3 radiographs of the right shoulder demonstrate a reverse-type right shoulder arthroplasty.Image quality is limited and the entire humeral implant is not included.There is no evidence of a dislocation or osseous fracture.On the first image from the right, there is an abnormally angulated glenoid fixation screw that appears fractured.There is a small amount of lucency at the osseous margin of the glenoid base plate.The visualized humeral implant shows normal fit and the overall arthroplasty alignment is maintained.Bone quality is osteopenic.Medical records were translated and review identified loosening of the glenoid components with broken screw shoulder on the right.Severe omarthrosis with posterior glenoid erosion and chronic supraspinatus rupture on the right.Arterille hypertension 3rd st.N.Glottis ca 2015 and recurrence 2018, radiotherapy usz, postactinic laryngitis.The patient reports an increase in pain in the last few weeks, so that he is very painful both at rest and during beta treatment.Novalgin and olfen are currently taken regularly.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report 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: 11744346
• Report Number: 0001822565-2021-01063
• Device Sequence Number: 3856887
• Product Code: KWS
• UDI-Device Identifier: 00889024269033
• UDI-Public: (01)00889024269033(17)290630(10)64351007
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 09/09/2021

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: 64351007
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 08/05/2021; 09/08/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 08/12/2021; 09/09/2021
• 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; Required Intervention
• Patient Age: 77 YR