MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPLREHENSIVE SHOULDER SYSTEM STANDARD TAPER ADAPTOR; EXTREMITIES IMPLANTS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Connective Tissue Disease (1786); Pain (1994); Loss of Range of Motion (2032)
Date of Event	02/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A2:dob 1953.G2: uk.D10 - medical product: catalog #: 115730, compr nano hmrl pps 30mm, lot # 659640.Catalog #: 113022, versa-dial 38x19x39 hum head, lot # 395410.Catalog #: 113952, sm hybrid glenoid base 4mm, lot # 729090.Catalog #: pt-113950, pt hybrid glen post regenerex, lot # 849750.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.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: 0001825034-2024-00795, 0001825034-2024-00804, 0001825034-2024-00805, 0001825034-2024-00806.H3 other text : remains implanted.
Event or Problem Description
It was reported that the initial right shoulder arthroplasty approximately 9 years ago.Subsequently about a month ago the patient reported unusual pain and a decrease in range of motion with referral for consultant and unknown treatment.Attempts have been made and there is no further information at this time.
Additional Manufacturer Narrative
(b)(4).It was further assessed that the pain was due to rotator cuff tear, therefore, this is a not reportable event as the device did not cause or contribute to the reported event.The rotator cuff is a group of muscles and tendons that surround the shoulder joint, keeping the head of the humerus firmly within the shallow socket of the shoulder.Rotator cuff injuries occur most often in people who repeatedly perform overhead motions or experience any sort of trauma to the shoulder.Degenerative tears can also occur because of gradual wearing down of the tendon.This degeneration naturally occurs as we age.Factors that lead to degenerative tears include repetitive stress, lack of blood supply, bone spurs, and increased age.Common symptoms of a rotator cuff tear include pain at rest or with activity, weakness, and crepitus.Typically, an anatomic shoulder is performed when the rotator cuff is stable and intact, and a reverse shoulder is performed for an insufficient rotator cuff.
Event or Problem Description
It was further assessed that the pain was due to rotator cuff tear, therefore, this is a not reportable event as the device did not cause or contribute to the reported event.

• Brand Name: COMPLREHENSIVE SHOULDER SYSTEM STANDARD TAPER ADAPTOR
• Common Device Name: EXTREMITIES IMPLANTS
• 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: 18954017
• Report Number: 0001825034-2024-00803
• Device Sequence Number: 8161129
• Product Code: HSD
• UDI-Device Identifier: 00880304217249
• UDI-Public: (01)00880304217249(17)250825(10)182780
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K060716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2024

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: Health Professional
• Device Expiration Date: 08/25/2025
• Device Model Number: N/A
• Device Catalogue Number: 118001
• Device Lot Number: 182780
• 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: 02/26/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 08/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2015
• 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: Other
• Patient Sex: Female
• Patient Weight: 64 KG