MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Loss of Range of Motion (2032)
Date of Event	08/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical records were provided and reviewed.Review of the available records identified the following : the patient underwent a revision procedure due to periprosthetic fracture.Per office notes, patient had mild pain post operatively.Two weeks prior, the patient stumbled over his cane.Increased pain.Difficulty ambulating.Bruising along the thigh.X-rays showed fracture of medial femur and lesser trochanter.During the revision procedure, there was periprosthetic fracture of the left femur and the stem was loose.There was a large resolving hematoma consistent with a two-week-old fracture.All was evacuated.The head and stem were replaced with new zimmer biomet products, and the fracture was mobilized using cables.No other findings/complications related to the reported event were noted.Review of the device history records identified no deviations or anomalies during manufacturing.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.
Event or Problem Description
It was reported the patient underwent a left tha.Subsequently, the patient was revised approximately 1 month later due to periprosthetic fracture.No further event information available at the time of this report.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10586999
• Report Number: 0001822565-2020-03356
• Device Sequence Number: 2707803
• Product Code: LPH
• UDI-Device Identifier: 00889024131729
• UDI-Public: (01)00889024131729(17)291130(10)64504801
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K032726
• 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
• Report Date (Section B): 09/25/2020

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: 00771100720
• Device Lot Number: 64504801
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 09/25/2020
• 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 CUP; UNKNOWN LINER; ZIMMER BIOLOXA HEAD CAT#00877503602 LOT#3005359
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 79