MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN BIPOLAR HEAD; PROSTHESIS, HIP

Model Number N/A

Device Problems Naturally Worn (2988); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pain (1994); Synovitis (2094)

Event Date 02/17/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Concomitant medical products: unk, unknown versys stem, unk, unk, unknown liner, unk, unk, unknown shell, unk.

Event Description

It was reported patient underwent surgical removal of the bipolar head prosthesis nine days post-implantation due to infection.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Single-use, sterilized devices manufactured or distributed by zimmer are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.Therefore, it is highly unlikely that the specified device caused any patient infection.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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

(b)(4).The reported event is confirmed via op notes.No products were returned; therefore, the visual and dimensional inspections were not performed.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.The review of the op notes identified that the coupling pin was fractured and the polyethylene bushing showed excessive wear.A definitive root cause cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.

Event Description

It was reported the patient underwent total elbow arthroplasty revision approximately ten (10) years post-implantation due to wear of the polyethylene bushings and fracture of the coupling pin.Patient was noted to be experiencing pain with range of motion and crepitus.Revision operative report notes dark black material within the joint and synovitis.A fractured prong of the pin was noted to be missing and unable to be retrieved from the soft tissue.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: UNKNOWN BIPOLAR HEAD
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6807674
• MDR Text Key: 83150448
• Report Number: 0001822565-2017-05856
• Device Sequence Number: 1
• Product Code: JDG
• 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: consumer,distributor,health p
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/13/2018

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 Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/26/2017
• Initial Date FDA Received: 08/21/2017
• Supplement Dates Manufacturer Received: 09/23/2017; 01/09/2018; 06/13/2018
• Supplement Dates FDA Received: 09/24/2017; 01/09/2018; 06/13/2018
• 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): Hospitalization; Required Intervention