MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZMR TAPER STEM LGE JNCT.22X185; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Blood Loss (2597)

Event Date 07/11/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as 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 during a revision, the patient experienced an estimated blood loss of 2500 ml.During the revision, complex removal of hip prosthesis, open reduction of femoral fracture, and incision/drain of abscess were completed.

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of operative notes which indicate estimated blood loss as 2500ml during procedure.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: ZMR TAPER STEM LGE JNCT.22X185
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7613260
• MDR Text Key: 111449038
• Report Number: 0001822565-2018-03299
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• PMA/PMN Number: PK992667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 07/12/2018

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: Physician
• Device Expiration Date: 10/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 00998202218
• Device Lot Number: 60806802
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/22/2018
• Initial Date FDA Received: 06/19/2018
• Supplement Dates Manufacturer Received: 07/12/2018
• Supplement Dates FDA Received: 08/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 00620205820 / 60778310 CUP; 00625006530 / 60829639 SCREW; 00625006530 / 60854337 SCREW; 00801803605 / 60156813 HEAD; 00999001940 / 60045979 BODY; 00620205820 / 60778310 CUP; 00625006530 / 60829639 SCREW; 00625006530 / 60854337 SCREW; 00801803605 / 60156813 HEAD; 00999001940 / 60045979 BODY
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR