MAUDE Adverse Event Report: ZIMMER BIOMET, INC. INTEGRAL PRIMARY/REV 15 X 180; PROSTHESIS, HIP

Model Number N/A

Device Problem Separation Failure (2547)

Patient Problems Pain (1994); Discomfort (2330); Reaction (2414)

Event Date 08/07/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: biomet offset metal punch cat#x31-400058 lot#498070, biomet taper adaptor removal assembly cat# 110005232 lot#448900, biomet m2a cup cat#us157864 lot#147820, biomet liner cat#139264 lot#232620, biomet m2a head cat#157458 lot#681540.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 03912, 0001825034 - 2019 - 03913.

Event Description

It was reported the patient underwent tha.Subsequently, patient was revised due to discomfort and fear of metallosis approximately 10 years later.The head, insert, and cup were removed and replaced.It was noted the magnum extractor was being used to remove the adapter that was stuck to the implanted stem.While turning the torque wrench, the bottom collar of the extractor broke.The handle that screws into extractor had screw threads that became disfigured.The magnum curved tamp was used so much that it became disfigured as well.It was noted there was a 60 minute delay.Surgery was completed with another device.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Review of the device history records identified no deviations or anomalies during manufacturing.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: INTEGRAL PRIMARY/REV 15 X 180
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8954054
• MDR Text Key: 156273805
• Report Number: 0001825034-2019-03914
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K030055
• 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: 11/13/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 166015
• Device Lot Number: 344660
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/08/2019
• Initial Date FDA Received: 09/02/2019
• Supplement Dates Manufacturer Received: 11/05/2019
• Supplement Dates FDA Received: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR