MAUDE Adverse Event Report: ZIMMER BIOMET, INC. IDENTITY REV -6MM EXTENDED NEUTRAL HUMERAL TRAY; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED/EXTREMITIES

Catalog Number	SAHTNEM6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical products: item#: 110044360, 36mm standard retentive bearing; lot#: 65854051.Item#: 110027734, compr vrs glen pps min tpr adr; lot#: 67077496.Item#: 115310, comp rvrs shldr glnsp std 36mm; lot#: j7799890.Item#: 110031378, versa-dial taper adaptor 25mm; lot#: 67077498.Item#: sahs1104, size 4 standard humeral stem; lot#: 66511654.Item#: 115399, comp rvs cntrl 6.5x45mm st/rst; lot#: 241360.Item#: 115400, comp rvs cntrl 6.5x50mm st/rst; lot#: 65888016.Item#: 180553, comp lk scr 3.5hex 4.75x30 st; lot#: 65940765.Item#: 180553, comp lk scr 3.5hex 4.75x30 st; lot#: 66654590.Item#: 180553, comp lk scr 3.5hex 4.75x30 st; lot#: 66918176.Item#: 180554, comp lk scr 3.5hex 4.75x35 st; lot#: 66890526.Item#: 180555, comp lk scr 3.5hex 4.75x40 st; lot#: 66198202.G2: foreign: japan.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was discarded by the hospital as biohazard.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial shoulder arthroplasty approximately two (2) months ago.Subsequently, the patient was revised due to infection approximately one (1) month ago.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, h2, h6.The following section was corrected: d5, h4, h6: component code.Product was not evaluation as it was determined the event is not related to the device.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, implanted products are not identified as the source or contributing to the reported infection.Root cause of the reported event is not device related.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 to report at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4; b5; d2; g2; g3; g6; h1; h2.The following section was corrected: d4: primary unique device identification (udi) number.Upon receiving additional information it was noted that the primary unique device identification (udi) number for the reported product was reported incorrectly.The number has been corrected.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: IDENTITY REV -6MM EXTENDED NEUTRAL HUMERAL TRAY
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED/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: 21764744
• Report Number: 0001822565-2025-00884
• Device Sequence Number: 8720986
• Product Code: MBF
• UDI-Device Identifier: 00889024627406
• UDI-Public: (01)00889024627406(17)340929(10)66984413
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K213856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 07/22/2025

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 Catalogue Number: SAHTNEM6
• Device Lot Number: 66984413
• 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: 03/10/2025
• Supplement Date Received by Manufacturer: 06/13/2025; 07/22/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 07/08/2025; 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2024
• 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: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown