MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ENDO II MOD ENDO HEAD SZ 44; PROSTHESIS, HIP

Model Number N/A

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

Patient Problem Blood Loss (2597)

Event Date 08/02/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 139245 endo ii taper insert +6 mm t1 637370, cp152445 bi-metric fmrl c intlk 9x300 l 890090, 11-165103 arcom rnglc tri- polar lnr sz27 190020.The complaint is under investigation.Once the investigation is completed a follow up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-08313, 0001825034-2018-08315, 0001825034-2018-08316.

Event Description

It was reported that the patient experienced blood loss of 1500 ml during re-implantation, following treatment of infection.No other additional information is available.

Event Description

No additional information is available to report at this time.

Manufacturer Narrative

The following report is being submitted to relay additional information received the complaint is confirmed based on the operative records provided.Review of the device history record identified no deviations or anomalies would contribute to reported event.A definitive root cause cannot be determined with the information provided.If any further information is found 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: ENDO II MOD ENDO HEAD SZ 44
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7802869
• MDR Text Key: 117795583
• Report Number: 0001825034-2018-08311
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• PMA/PMN Number: PK984028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• 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: 12-139012
• Device Lot Number: 708590
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR