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

Device Problems Unstable (1667); Malposition of Device (2616); Osseointegration Problem (3003); Unintended Movement (3026); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Osteolysis (2377)

Event Date 06/23/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the device will not be released by hospital.The investigation is in process.Once the investigation is complete, a follow ¿up mdr will be submitted.Concomitant medical products: item# 00620206220 / tm mod cup multi-hole / lot # unknown.Item# unknown / unknown bone screw / lot # unknown/quantity 4.Item# 00631006236/ tm mod liner 36mm/ lot # unknown.Item# unknown/ unknown allo-pro femoral stem/ lot# unknown.Item# unknown/ unknown competitor head/ lot # unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2020 -02422.0001822565 -2020 -02427.0001822565 -2020 -02428.0001822565 -2020 -02429.0001822565 -2020 -02430.

Event Description

It was reported patient underwent right hip revision surgery 9 years post implantation due to shell loosening and instability.Shell, liner, screws and competitor head were revised.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 and/or corrected information.Medical records were reviewed and revealed that the patient underwent a primary right hip arthroplasty in 1988, and underwent revision of right acetabular cup due to wear in 1995.2nd revision was performed due to pain, loosening, and lack of boney ingrowth of shell.During the revision, new zimmer biomet trilogy cup, liner, and bone screws were implanted.A competitor's head was used as the surgeon did no have other heads available for the 14-16 french trunnion on the allo-pro femoral stem.The cup was implanted at approximately 45 degrees inclination and at 25-30 degrees anteversion.Good stability and range of motion were achieved.No complications occurred.The patient was revised again due to loosening of the cup and instability.The operative notes for the 2020's revision procedure were not provided.Device history record (dhr) review was unable to be performed as the 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.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 further event information available at the time of this report.

• Brand Name: UNKNOWN BONE SCREW
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10242409
• MDR Text Key: 197932985
• Report Number: 0001822565-2020-02423
• 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
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention