MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 8MM MINI; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED / EXTREMITIES

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330)
Date of Event	09/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-02038, 0001825034-2021-02039.Medical products: item#: unknown, unknown glenosphere; lot#: unknown; item#: unknown, unknown humeral bearing; lot#: unknown.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Medical records were not 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
It was reported that the patient underwent an initial shoulder arthroplasty approximately eighteen years ago for unknown reason.Subsequently, the patient was revised approximately two years ago due to proximal humorous fracture.The patient underwent a second revision approximately three months after first revision due to prosthesis subluxation and tuberosity fracture of their humeral head.Approximately a month after second revision the patient's shoulder was infected and another surgical procedure was performed for the infection.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-02038-1, 0001825034-2021-02039-1.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
It was reported that the during i&d cultures procedure revealed that the patient was positive for enterococuss, faecalis, and staphylococcus epidermidis species of unknown significance.Subsequently, the care of the patient was transferred to an infectious disease specialist approximately four (4) weeks after revision surgery.The patient was also diagnosed with a prothesis joint infection at that time.The patient was under this physicians care for approximately one (1) year after the revision surgery.The patient continues to have pain, discomfort and limited use of shoulder.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-02038-2.0001825034-2021-02039-2.The following sections were updated: b4; b5; g3; g6; h1; h2.Investigation remains unchanged from the previous investigation.Additional legal records were provided, however, the complaint categories and harms were already accounted for previously.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
(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-02038-3, 0001825034-2021-02039-3.D10: medical products: item#: 115316, comp rvrs shldr glnsp +6 36mm; lot#: 693520, item#: 010000589, comp rvrs 25mm bsplt ha+adptr; lot#: 147030, item#: 115394, comp rvs cntrl 6.5x20mm st/rst; lot#: 225870, item#: 180550, comp lk scr 3.5hex 4.75x15 st; lot#: 361000, item#: 180552, comp lk scr 3.5hex 4.75x25 st; lot#: 236420, item#: 180551, comp lk scr 3.5hex 4.75x20 st; lot#: 795350, item#: 180550, comp lk scr 3.5hex 4.75x15 st; lot#: 361000, item#: 118000, 25mm versa-dial taper adaptor; lot#: 139850, item#: 110031400, mini tray +5mm cocr +0 offset; lot#: 64345689, item#: 110031420, cr prolong 36mm brng +3 ret; lot#: 64291333.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, therefore implanted products are not identified as the source or contributing to the reported infection.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.

• Brand Name: COMP PRIMARY STEM 8MM MINI
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED / EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12154564
• Report Number: 0001825034-2021-02040
• Device Sequence Number: 3490627
• Product Code: MBF
• UDI-Device Identifier: 00887868267758
• UDI-Public: (01)00887868267758(17)290604(10)092560
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K193038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/31/2022
• 2 Devices were Involved in the Event: 1 2

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 Model Number: N/A
• Device Catalogue Number: 113628
• Device Lot Number: 092560
• 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: 06/17/2021
• Supplement Date Received by Manufacturer: 11/18/2021; 12/02/2021; 05/31/2022
• Initial Report FDA Received Date: 07/12/2021
• Supplement Report FDA Received Date: 12/03/2021; 12/10/2021; 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2019
• 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; SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male