MAUDE Adverse Event Report: ZIMMER GMBH ANATOMICAL SHOULDER¿¢ REVERSE, SCREW SYSTEM, 4.5-42; SHOULDER IMPLANT

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cognitive Changes (2551)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent initial shoulder arthroplasty approximately twelve (12) years ago.Subsequently, it was reported that patient had ongoing cognitive impairment and delay that started after his surgery.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: therapy date :unknown base plate uncemented item 00434903811 lot 61955510 36mm ã¿ glenosphere item 00434903611 lot 61949538 12mm ã¿ 130mm length humeral stem item 00434901213 lot 61855815 36mm ã¿ +6mm offset poly liner item 00434903606 lot 61891901 customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.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 additional information at this time.
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.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Cognitive impairment is described as the inability to think, memory loss, understanding, remembering, use of judgement or solving problems, decision making skills, being unaware of surrounding, and mood changes, to name a few.These symptoms can be mild or severe which is labeled dementia and/or early signs of alzheimer's disease.Some of the causes of cognitive impairment can be related to medication side effects, delirium from an illness (such as uti), depression, vitamin deficiencies, metabolic or endocrine dysfunction, head injury, blood clots or brain tumors, alcohol consumption, vascular dementia, lewy body dementia, and frontotemporal disorders.Cognitive impairment is also an impairment as we age with getting more forgetful, loss of thought process, and decrease decision skills.It was reported the patient has cognitive impairment since initial surgery with no cause or severity of the impairment provided.This was a request for composition of our component without specific allegations to the component.Based on the available information, the reported event cannot be confirmed and 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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ANATOMICAL SHOULDER¿¢ REVERSE, SCREW SYSTEM, 4.5-42
• Common Device Name: SHOULDER IMPLANT
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 19134683
• Report Number: 0009613350-2024-00143
• Device Sequence Number: 14652336
• Product Code: KWS
• UDI-Device Identifier: 00889024483057
• UDI-Public: (01)00889024483057(17)161031(10)2611617
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K990136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 0104223042
• Device Lot Number: 2611617
• 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: 03/26/2024
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2011
• 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: SE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male