MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ORTHOPEDIC SALVAGE SYSTEM COMPRESS SPINDLE; PROSTHESIS, KNEE

Device Problems Inadequacy of Device Shape and/or Size (1583); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported that a patient underwent a total knee procedure on an unknown date.It was reported by the surgeon that insufficient inventory was available to implant the appropriate diameter spindle component.Subsequently, on an unknown timeframe post-implantation, the implanted component failed.A revision surgery is pending.Due diligence is in progress for this complaint; to date no further information has been reported.

Manufacturer Narrative

(b)(4).D10: medical product: unknown oss cps anchor plug: catalog#ni, lot#ni; unknown oss cps taper adaptor: catalog#ni, lot#ni; unknown oss diaphyseal segment: catalog#ni, lot#ni; unknown oss distal femoral component the product will not be returned to zimmer biomet for investigation, as the product currently remains implanted.The investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.

• Brand Name: UNKNOWN ORTHOPEDIC SALVAGE SYSTEM COMPRESS SPINDLE
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18934194
• MDR Text Key: 338033720
• Report Number: 0001825034-2024-00768
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/19/2024
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose