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

Model Number N/A

Device Problem Corroded (1131)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Reaction (2414)

Event Date 05/10/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).It is unknown if product is being returned to zimmer biomet for investigation; however, an investigation has been initiated.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: 0001822565-2017-02180; 0001822565-2017-02181; 0001822565-2017-02244.

Event Description

Legal counsel for patient reported patient was revised three years post-implantation due to discomfort, pain, and a tissue mass within the ileopsoas bursa suggestive of a metal-on-metal pseudotumor.Legal counsel further reported that during the procedure, there were signs of corrosion at the neck and stem junction, malfunction of the acetabular ring, and acetabular osteolysis.Attempts to obtain additional information have been made; however, no more is available at this time.This report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Device history report review was unable to be performed as the lot number of the device involved in the event is unknown.Reported event was unable to be confirmed as part number / lot number of device involved in the incident was unknown.Root cause was unable to be determined.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

Upon receipt of additional information, it has been determined that this device is not a zimmer biomet product.The initial reports were submitted in error and should be voided.

Event Description

Upon receipt of additional information, it has been determined that this device is not a zimmer biomet product.The initial reports were submitted in error and should be voided.

• Brand Name: UNKNOWN STEM
• 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: 6487483
• MDR Text Key: 72653142
• Report Number: 0001822565-2017-02180
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2019
• 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