MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN BIOMET INTERGRAL 180, PRIMARY STEM 14*180; PROSTHESIS, HIP

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

Patient Problem Blood Loss (2597)

Event Date 04/19/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 163663 28mm dia cocr mod hd +3mm nk 145750,, unknown stryker trident acetabular component size 62 mm unknown, unknown screws 24, 26, 35 and 40 unknown, unknown standard mdm metal liner 48 id unknown, unknown stryker 48mmx3 adm femoral head poly (48 od, 28id) unknown.Customer has indicated that product will not be returned for evaluation.A follow up mdr will be submitted once the investigation is completed.

Event Description

It was reported that during a left hip revision arthroplasty the patient experienced 2600 ml blood loss.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of the provided op notes which confirmed the patient's blood loss.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Non- zimmer biomet shell and liner are used with zimmer head and stem.Zimmer-biomet has not assessed or confirmed the compatibility of this combination of devices, and this would be considered an off-label use of these devices.However it is unknown if this combination of devices has any effect to the reported issue 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.

Manufacturer Narrative

The follow up report is been submitted to relay additional information received.The additional information received does not have any change in investigation results reported previously.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.

• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7500874
• MDR Text Key: 107821427
• Report Number: 0001825034-2018-03258
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR