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

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted.
Event or Problem Description
It was reported patient is experiencing range of motion issues in extension since the locking screw was revised.No further information is available at the time of this reporting.
Event or Problem Description
No further information is available at the time of this reporting.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Multiple mdr's are associated with this reporting: 0001822565 - 2020 - 00199, 0001822565 - 2020 - 00200.Updated: d11, h2, h3, h6, h10.Reported event was unable to be confirmed due to the limited information received from the customer.Device history record (dhr) review was performed with no related manufacturing deviations or anomalies identified.Root cause is unknown.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.

• Brand Name: EXPLOR IMPLANT LOCKING SCREW
• Common Device Name: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9027210
• Report Number: 0001825034-2019-04057
• Device Sequence Number: 16683276
• Product Code: KWI
• UDI-Device Identifier: 00880304210493
• UDI-Public: 00880304210493
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K051385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2020

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: 690690
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 01/16/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN PART/LOT, UNKNOWN HEAD; UNKNOWN PART/LOT, UNKNOWN STEM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 94