MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 12MM ÿ 130MM LENGTH HUMERAL STEM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Model Number	00-4349-012-13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Muscle Hypotonia (4531); Muscle/Tendon Damage (4532)
Date of Event	08/20/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent radiographic imaging, approximately one (1) year post-operatively and a stress fracture of the greater tuberosity stem was discovered on imaging.The patient was prescribed tylenol three.Approximately six (6) months after the fracture was discovered, the patient underwent a right shoulder revision surgery due to acute onset of pain and increased difficulty performing daily activities.The poly was revised and a pectoralis major repair was performed.The surgeon noted the patient displayed muscle atrophy to surrounding tissues.No further information has been reported.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-02674.Concomitant medical products: item#: 00434903603, 36mm a +3mm offset poly liner; lot#: 62114032.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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.H6: component codes: mechanical(g04)- stem.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: (b)(6) 2014; visit: greater tuberosity stem fracture due to carrying luggage around during recent travel to japan prescribed tylenol 3 (b)(6) 2014; visit: pain rate 06.3 cm with average of taking two pills each day (has otc and narcotic pain medication).Difficulty performing daily functions d/t pain anteroposterior and axillary x-rays: greater tuberosity stress fracture (b)(6) 2014; ae acute onset of severe pain (b)(6) 2014; operation poly exchange and pec major repair; reports acute pain onset (b)(6) 2014 no intra-op complications/events.It was indicated that the fracture occurred due to carrying luggage; however, with the information provided 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: 12MM ÿ 130MM LENGTH HUMERAL STEM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15433031
• Report Number: 0001822565-2022-02701
• Device Sequence Number: 12263341
• Product Code: HSD
• UDI-Device Identifier: 00889024268951
• UDI-Public: (01)00889024268951(17)230131(10)62248463
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2022

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: 01/31/2023
• Device Model Number: 00-4349-012-13
• Device Catalogue Number: 00434901213
• Device Lot Number: 62248463
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2022
• Supplement Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2013
• 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: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 78 KG