MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP NLK SCR 3.5HEX 4.75X30 ST; FASTENER, FIXATION

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical product: catalog #: 115310, comp rvrs shldr glnsp std, lot # 670930, catalog #: 115397, comp rvs cntrl, lot # 172790, catalog #: 115330, comp rvrs shdr glen bsplt, lot # 415440, catalog #: 113653, comp primary stem 13mm std, lot # 921870, catalog #: 118001, versa-dial/comp ti std taper, lot # 411920, catalog #: ep-115395, e1 44-36 rtnv +3 hmrl brg, lot # 386560, catalog #: 115378, comp rvs tray +10mm co 44mm, lot # 800090, catalog #: 180560, comp nlk scr 3.5hex 4.75x30 st, lot # 541780, catalog #: 180553, comp lk scr 3.5hex 4.75x30 st, lot # 472190, catalog #: 180552, comp lk scr 3.5hex 4.75x25 st, lot # 593030, catalog #: 180561, comp nlk scr 3.5hex 4.75x35 st, lot # 251830.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.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-04951, 0001825034-2019-04952, 0001825034-2019-04953, 0001825034-2019-04954, 0001825034-2019-04955, 0001825034-2019-04956, 0001825034-2019-04957, 0001825034-2019-04987, 0001825034-2019-04988, 0001825034-2019-04991.Remains implanted.
Event or Problem Description
It was reported that patient is still experiencing pain approximately two years post-implantation.No further information is available at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.
Additional Manufacturer Narrative
(b)(4).Upon further assessment it was discovered that this implant was not in situ when the patient complained of further pain.It had already been explanted.Therefore it will be voided.
Event or Problem Description
Upon further assessment it was discovered that this implant was not in situ when the patient complained of further pain.It had already been explanted.Therefore it will be voided.

• Brand Name: COMP NLK SCR 3.5HEX 4.75X30 ST
• Common Device Name: FASTENER, FIXATION
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 9279459
• Report Number: 0001825034-2019-04986
• Device Sequence Number: 2158150
• Product Code: KWS
• UDI-Device Identifier: 00880304677272
• UDI-Public: (01)00880304677272
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K080642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/04/2024

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: 06/17/2026
• Device Model Number: N/A
• Device Catalogue Number: 180560
• Device Lot Number: 541780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 02/05/2020; 03/07/2024
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 02/10/2020; 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2017
• 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: Other
• Patient Sex: Male