MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ANATOMICAL SHOULDER, HUMERAL STEM, UNCEMENTED, 10.5, 100 MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Cmp-0894168 d10 - medical devices: item#: 0104223366, lot#: 2997859, item name: anatomical shoulder reverse, humeral insert, pe, 36-6 item#: 0104223106, lot#: 3028366, item name: anatomical shoulder reverse, humeral cup, retro, / mm medial offset item#: 0104440006, lot#: 2999376, item name: baseplate, s, 25mm item#: 0104441024, lot#: 3019020, item name: trabecular metal peg, 24mm item#: 0104441021, lot#: 3016858, item name: trabecular metal peg, 21mm item#: 0104440073, lot#: 2977628, item name: taper adaptor, s item#: 0104440068, lot#: 3015759, item name: glenosphere g2 - foreign: switzerland the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that patient underwent a reverse left shoulder arthroplasty.During surgery the humeral bone fractured while the surgeon was implanting the stem.No known impact or consequence to the patient.The fracture was treated conservatively.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).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 that could be related to the reported event.Device is used for treatment.Both the crf as well as the implantation report were received and assessed by a healthcare professional with the following findings: the patient, 1.5 years after experiencing a humeral head fracture and undergoing three subsequent operations, presented with almost complete loss of shoulder function and persistent pain.These symptoms were attributed to humeral head necrosis and malunion/nonunion.A ct scan revealed poor bone quality in the glenoid region, likely contributing to the patient's shoulder issues.An interscalene block was administered for pain management and functional assessment.The surgical approach involved the deltopectoral approach, a specific technique for accessing and treating the shoulder joint.Significant scar tissue, especially in the lateral aspect of the deltopectoral interval, was excised during the procedure.The soft tissues surrounding the shoulder were noted to be hyperemic, thickened, and potentially indicative of infection, necessitating further examination.The deltoid muscle appeared thin and pale, likely contributing to the loss of shoulder function.Pseudoarthrosis resection was performed, addressing the development of a false joint, often as a complication of a fracture.A ventral-medial perforation was observed and filled with cancellous bone during the procedure.While the subscapularis muscle was not released, the anterior, posterior, and inferior capsule of the shoulder joint were released during surgery.The bicep tendon was tenotomized during the operation.The initial attempt to reduce the shoulder joint was unsuccessful due to tension.As a result, the decision was made to insert the humeral stem 1cm deeper.The glenosphere, a component of the shoulder implant, was modified, resulting in a successful reduction.A definitive press-fit stem size of 10.5 was used, with specific measurements and adjustments to improve joint function.Radiological images revealed an undislocated fissure in the axial plane distal to the shaft with cortical interruption.The decision was made to treat this fissure conservatively, as it was not visible in the anterior-posterior image.The patient had a history of humeral bone fracture, which had been managed conservatively and resolved by (b)(6) 2021.Following the surgical procedures and evaluations, the patient was hospitalized for seven days and subsequently discharged home.Contributing factors of event: avascular necrosis, osteoporotic bone, clear rotator cuff deficiency; prior left proximal humeral fracture with 3 follow-up operations.Additionally, two undated x-rays of the left shoulder were received, but not reviewed as sufficient documentation is contained within the surgical note.A submission of these images to radiologists would not further enhance the investigation.Based on the given information and results of the investigation, the reported event may be potentially related to the patient's comorbidities and/or past medical history.However, a definitive root cause cannot 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, HUMERAL STEM, UNCEMENTED, 10.5, 100 MM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING 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: 17743081
• Report Number: 0009613350-2023-00517
• Device Sequence Number: 5281758
• Product Code: PHX
• UDI-Device Identifier: 00889024484917
• UDI-Public: (01)00889024484917(17)250131(10)3014388
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K193099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2023

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: 01/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 01.04201.103
• Device Lot Number: 3014388
• 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: 08/22/2023
• Supplement Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 53 KG