MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STAGE ONE SELECT HIP STEM CEMENT SPACER MOLD; PROSTHESIS HIP

Model Number N/A

Device Problems Bent (1059); Noise, Audible (3273)

Patient Problem Pain (1994)

Event Date 04/20/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products - freedom all poly cup 50mm, # item 11-107122 lot unk, freedom constr hd 36mm, t1 +6mm # item 11-107020 lot unk, palacos r 1x40 single # item 00-1112-140-01 lot unk.It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent a revision surgery of a cement mold stem 7 days post stage 1 revision surgery.She was inserted with a cement spacer mold, and when she was being transferred to the wheelchair she heard a pop and then had pain.She was re-admitted to orthopedics 4 days post implantation of the initial cement mold stem and underwent revision surgery.The surgeon found the initial cement mold to be bent.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.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: STAGE ONE SELECT HIP STEM CEMENT SPACER MOLD
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7588794
• MDR Text Key: 110699953
• Report Number: 0001825034-2018-03892
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: PK080979
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 431195
• Device Lot Number: 224060
• Other Device ID Number: (01) 0 0880304 52112 4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 84