MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CORTICAL BONE SCR 5.0MM X 42MM; PROSTHESIS, TRAUMA

Catalog Number 814550042

Device Problem Fracture (1260)

Patient Problems Non-union Bone Fracture (2369); Osteopenia/ Osteoporosis (2651)

Event Date 12/17/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-00014, 0001825034-2021-00015.Concomitant medical devices: item# 814611380; lot# 059310; item# 814510105; lot# ug1111305d; item# 814501090; lot# dnccm1; item# 814550046; lot# unk.Foreign - event occurred in (b)(6).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 Description

It was reported patient underwent an arthroplasty approximately seven (7) months ago.Subsequently, patient was revised four (4) months post-implantation due to non-union of the fracture and fracturing of the nail and lag screw.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

Visual examination of the returned product identified the cortical bone screw (part 814550042) is fractured.Not all pieces were returned.Device was submitted for further analysis.Analysis determined for the fractured screw (part 814550042 lot unk, sem 2105-011) showed that it fractured due to fatigue.Fracture surface showed fatigue artifacts such as beach marks and ratchet marks.Suspected crack initiation area and crack propagation direction were identified.Suspected crack exit region on the fracture surface identified by bending hinge.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: there is a mildly displaced fracture of the proximal femoral intramedullary nail with varus angulation at the proximal femoral fracture site, which is not united.The more proximal of the two distal interlocking screws is also fractured.There is abnormal varus alignment at the proximal femur fracture site.Bone quality is osteopenic.Patient anatomy appears unremarkable and no contributing factors are identified.There is no radiographic evidence of trauma.Lot identification is necessary for review of device history records, lot identification was not provided.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: CORTICAL BONE SCR 5.0MM X 42MM
• Type of Device: PROSTHESIS, TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11444546
• MDR Text Key: 238633024
• Report Number: 0001825034-2021-00672
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K100238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 814550042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention