MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXPLOR IMPLANT LOCKING SCREW; PROSTHESIS, ELBOW

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 11-210033 994720 explor 14x22mm implant head, unknown schaft explor.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location of the device 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 - 05521.
Event or Problem Description
It was reported patient¿s elbow was revised approximately six months post implantation due to dislocation of the head and the locking screw.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
Reported event was unable to be confirmed due to limited information received from the customer.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified implant disassembly.Overall sizing of the radial head implant appears to be appropriate.No factors are identified which may have contributed to the alleged event.The device history record (dhr) 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 report 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: EXPLOR IMPLANT LOCKING SCREW
• Common Device Name: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9445490
• Report Number: 0001825034-2019-05520
• Device Sequence Number: 14012503
• Product Code: KWI
• UDI-Device Identifier: 00880304210493
• UDI-Public: (01)00880304210493
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K051385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/20/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-210099
• Device Lot Number: 903300
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 12/10/2019; 03/04/2020
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 01/02/2020; 03/20/2020
• 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
• Patient Age: 61 YR
• Patient Weight: 75