MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS CNTRL 6.5X20MM ST/RST; FASTENER, FIXATION

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: catalog #: 115370, comprehensive reverse tray, lot # 812250, catalog #: 010000589, comp rvrs 25mm bsplt ha+adptr, lot # 094640, catalog #: 115310, comp rvrs shldr glnsp std 36mm, lot # 341040, catalog #: ep-115395, e1 44-36 rtnv +3 hmrl brg, lot # 961540, catalog #: 405800 , comp.Rev shldr 9 in steinmann, lot # 462740, catalog#: 180551, comp lk screw, lot #: 042460, catalog#: 180550, comp lk screw, lot #: 378700, catalog#: 180550, comp lk screw, lot #: 699700.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-05083, 0001825034-2019-05084, 0001825034-2019-05085, 0001825034-2019-05099, 0001825034-2020-00655, 0001825034-2020-00656, 0001825034-2020-00658, 0001825034-2020-00659, 0001825034-2020-00660.Product will not be returned.
Event or Problem Description
It was reported that the patient had an initial surgery approximately a year ago.Subsequently, the patient had a revision about 2 months later due to a post operative infection and a 2 stage antibiotic spacer placement.Attempts have been made and no further information has been provided.
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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: COMP RVS CNTRL 6.5X20MM ST/RST
• Common Device Name: FASTENER, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9700185
• Report Number: 0001825034-2020-00660
• Device Sequence Number: 3007442
• Product Code: KWS
• UDI-Device Identifier: 00880304677067
• UDI-Public: (01)00880304677067(17)280619(10)933530
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K132239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2020

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 Model Number: N/A
• Device Catalogue Number: 115394
• Device Lot Number: 933530
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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: Hospitalization; Required Intervention