MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR NECK B 12/14 NECK TAPER USE WITH +0 HEADS ONLY; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Blood Loss (2597)

Event Date 09/08/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00771301300, modular femoral stem press-fit plasma sprayed cementless size 13.5, 61084427, 01.00634.060, zimmer mmc cup 60mm/52mm code r, 2520711, 0100181520, metasul large diameter head 52/r, 2388089, 01.00185.146, head adapter m/0 12/14-18/20, 2506530.Customer has indicated that the product will not be returned to zimmer biomet for investigation, [product location 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 the patient's right hip revision, suffered blood loss of 1500ml.Cell saver was used to reinfuse 350ml back to the patient.No additional information available.

Manufacturer Narrative

Upon review of the event, it has been determined that this event was a result of a coinciding procedure, and will be reported under medwatch 0001822565-2017-03613.The initial report was forwarded in error and should be voided.

Event Description

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

• Brand Name: MODULAR NECK B 12/14 NECK TAPER USE WITH +0 HEADS ONLY
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8339820
• MDR Text Key: 136158701
• Report Number: 0001822565-2019-00329
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K063251
• 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: 03/14/2019

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 Expiration Date: 11/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 00784802200
• Device Lot Number: 61346693
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2019
• Initial Date FDA Received: 02/14/2019
• Supplement Dates Manufacturer Received: 03/12/2019
• Supplement Dates FDA Received: 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1