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

Model Number N/A

Device Problems Corroded (1131); Material Discolored (1170); Material Erosion (1214); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Local Reaction (2035); Osteolysis (2377); Reaction (2414); Limited Mobility Of The Implanted Joint (2671)

Event Date 06/29/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: 00801803603 ¿ cocr head ¿ 61002371; unknown cup ¿ unknown part and lot; unknown liner ¿ unknown part and lot.Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product location is unknown.The investigation is in process and a follow-up mdr will be submitted upon completion.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2020 - 00352.

Event Description

It was reported that patient underwent a hip revision approximately 12 years post implantation due to metallosis found at the head/neck junction.During the surgery, the and liner were removed and replaced.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 confirmed due to limited information provided by the customer.Photos of the stem and explanted head were provided and visual review showed discoloration on the head¿s taper and stem¿s trunnion.Dhr was unable to be reviewed as the lot number of the device is unknown.The root cause is 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.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated / corrected.An updated investigation is in process.Once the investigation is completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-03978.

Event Description

It was reported that patient underwent a right hip revision approximately 12 years post implantation due to pain, limited and painful range of motion, elevated metal ion levels, positive mri scan, osteolysis, pseudotumor, altr, metallosis and corrosion.The head and liner were removed and replaced.Operative report notes corrosion at bottom of femoral head.Head was removed and corrosive material inside taper of the head as well on surface of trunnion was found.Osteolysis found on acetabulum.Metal was uncovered due to osteolysis.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 confirmed by review of medical records noting patient underwent a revision due to failed hip arthroplasty.Radiating pain in the hip along with limited daily activities for life, and limited range of motion.Blood work revealed elevated metal ion levels and during the surgery, corrosion was found on the stems trunnion.Osteolysis was noted around the cup and pseudotumor, adverse local tissue reaction found in the joint.Additional information does not change the conclusions of the previous investigation.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: UNKNOWN STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10313415
• MDR Text Key: 200253180
• Report Number: 0001822565-2020-02636
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 52