MAUDE Adverse Event Report: ZIMMER BIOMET, INC. INTER-OP HEMI/POR.SCR.HOLES 57 SCREWHOLES; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Blood Loss (2597)

Event Date 10/26/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent a left hip revision.During the removal of the stem component, the gouge used to remove the cement perforated the femur.The femur was repaired with cables.As the surgeon was reaming for a new stem, the perforation continued to fracture distally.The revision procedure ended up taking about three and a half hours.It was also noted that during the surgery, the patient experienced about 800ml of blood loss however, no medical intervention was noted.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.

Event Description

No additional information available.

• Brand Name: INTER-OP HEMI/POR.SCR.HOLES 57 SCREWHOLES
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8469021
• MDR Text Key: 140440021
• Report Number: 0001822565-2019-01308
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K972393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 436000057
• Device Lot Number: 1313489
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/05/2019
• Initial Date FDA Received: 04/01/2019
• Supplement Dates Manufacturer Received: 06/11/2019
• Supplement Dates FDA Received: 06/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Weight: 73