MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PRX HUM LO PLT LT 4H 83MM; TRAUMA IMPLANT

Model Number	N/A
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported in a study that one of the locking screws was pulled out.The patient was enrolled as subject in a study and when he visited the hospital for his three month follow-up visit where screw removal was found.The pulled screw came out through the skin and the patient manually removed it by himself.The patient had moderate pain and after the removal of screw, the pain was relieved.Attempts have been made and there is no further information at this time.
Additional Manufacturer Narrative
(b)(4).Date of birth: (b)(6).Medical product: catalog #: 110030101, prx hum lo plt lt 4h 83mm, lot # rm901p.Catalog #: 816140034, 4.0mm canc lock screw 34mm, lot # unknown.Catalog #: 816140042, 4.0mm canc lock screw 42mm, lot # unknown.Catalog #: 816140040, 4.0mm canc lock scrw 40mm, lot # unknown qty.2 catalog #: 816140042, 4.0mm canc lock screw 42mm, lot # unknown.Catalog #: 110018054, screw t15 md 3.5x54mm ns, lot # unknown.Catalog #: 110018056, screw t15 md 3.5x56mm ns, lot # unknown.Catalog #: 816135024, 3.5mm cort lock scr 24mm ns, lot # unknown qty 3.Catalog #: 110017724, screw t15 lp cort 3.5x24mm ns, lot # unknown.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was requested but not returned by the hospital.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: 0001825034-2022-00123.
Event or Problem Description
No additional event information is available at the time of this report.
Additional Manufacturer Narrative
Reported event was confirmed by review of radiographs.Review of the available records identified the following: plate and screw fixation of the proximal left humeral fracture is present.There is no hardware failure and fracture alignment is anatomic.One of the screws is suboptimally positioned with the screw head extending laterally to the plate.Bone quality is osteopenic.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.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: PRX HUM LO PLT LT 4H 83MM
• Common Device Name: TRAUMA IMPLANT
• 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: 13306601
• Report Number: 0001825034-2022-00125
• Device Sequence Number: 3346379
• Product Code: HRS
• UDI-Device Identifier: 00887868134708
• UDI-Public: (01)00887868134708(11)210217(10)RM901P
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K143697
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110030101
• Device Lot Number: RM901P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2022
• Supplement Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 01/20/2022
• Supplement Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2021
• 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.
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 70 KG