MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HFN A/R SCREW 95MM; PROSTHESIS, TRAUMA

Catalog Number	814501095
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Osteopenia/ Osteoporosis (2651)
Date of Event	10/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-03729.Concomitant medical devices: part# 814511180; lot# unk; part# 814510115; lot# vk1121315a; part# 814550040; lot# unk.Foreign - event occurred in denmark.Product has been received by zimmer biomet and 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 approximately one (1) year and four (4) months ago, patient was implanted with an unknown affixus nail to repair a trochanter femoris fracture on the right side.Approximately seven (7) months post-op, the patient fell.Xrays were taken approximately four (4) months ago due to patient experiencing pain, and x-rays had shown the nail had fractured.Patient was revised approximately two (2) months ago to remove the nail.During the surgery, a screw was also discovered to have fractured.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Visual inspection of the returned products noted the nail and screw fracture.The returned parts were sent to sem for additional evaluation.For screw - suspected fatigue crack initiation area near the edge of the screw, which appeared to be smeared.Fracture surface revealed artifacts that were consistent with fatigue mode, exhibiting fatigue striations.Suspected crack exit area identified near the opposite end of the screw fracture showing the transition from fatigue to overload mode of fracture with ductile dimples.Medical records were not provided.X-rays provided were sent to an external hcp for review.Their review noted the following: implant fit and alignment appear maintained although as noted one of the femoral neck surgical screws is fractured.Bone quality is osteopenic.Device history records was reviewed and no discrepancies relevant to the reported event were found.It was mentioned that the patient fell in (b)(6) 2020, which could potentially lead to the fracture of the implants.A definitive root cause cannot 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: HFN A/R SCREW 95MM
• Common Device Name: PROSTHESIS, TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11021565
• Report Number: 0001825034-2020-04368
• Device Sequence Number: 19737448
• Product Code: HSB
• UDI-Device Identifier: 00887868038747
• UDI-Public: (01)00887868038747
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K100238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2021

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 Catalogue Number: 814501095
• Device Lot Number: UK1111295B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 02/25/2021
• 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: 89 YR