MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CORTICAL BONE SCR 5.0MM X 38MM; PROSTHESIS, TRAUMA

Catalog Number	814550038
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Patient Problem/Medical Problem (2688)
Date of Event	05/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-02358, 0001825034-2020-02360, 0001825034-2020-02361.Concomitant medical products: part#: 814509180, lot#: 661770.Part#: 814510115, lot#: vk1121315c.Part#: 814501105, lot#: th1211305c.Part#: 903003004, lot#: unk.Part#: 211201505, lot#: unk.Part#: 211201405, lot#: unk.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is not available to be returned per hospital policy.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.
Event or Problem Description
It was reported that the initial surgery was approximately two (2) months ago.At the three (3) week check-up, surgeon was satisfied with follow up films.Approximately one (1) month post-implantation, obese patient fell and apparently "hobbled" on it for five (5) days before being removed.All implants were intact.Surgeon implanted a total hip because the lag screw penetrated through the femoral head (ie.Cut out).
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined to be not reportable.It was reported the lag screw penetrated through the femoral head and all other implants remained intact.The initial report was forwarded in error and should be voided.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: CORTICAL BONE SCR 5.0MM X 38MM
• Common Device Name: PROSTHESIS, TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10153506
• Report Number: 0001825034-2020-02359
• Device Sequence Number: 2318956
• Product Code: HSB
• UDI-Device Identifier: 00887868039492
• UDI-Public: (01)00887868039492
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K111444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2020

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 Catalogue Number: 814550038
• Device Lot Number: M18817A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/26/2020
• Supplement Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 06/15/2020
• Supplement Report FDA Received Date: 10/14/2020
• 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: NI
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 126