MAUDE Adverse Event Report: ZIMMER TMT TM ACETABULAR REVISION SYSTEM SHIM AUGMENT 15º; TM SHIM

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 04/19/2014

Event Type  Injury  

Manufacturer Narrative

A review of the implant's manufacturing record indicates that it was manufactured to specification.Based on the information available, the root cause of the event cannot be determined.Should additional information be obtained to further this investigation, this report shall be updated.

Event Description

It was reported that the patient underwent an emergency procedure due to plantarflexion 2 hours post-implantation.

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.The following sections were update/corrected.Updated: b4, b5, g4, g7, h2, h3, h6.Medical records were provided and reviewed.Medical records identified that patient was diagnosed with pelvic chondrosarcoma approximately 1 month prior to implantation.Patient underwent a hemipelvectomy, exploration of the femoral arteries, common iliac artery and vein, femoral and sciatic nerves, radical resection of the soft tissue component of anterior column/pubic rami sarcoma, resection of femoral head, acetabular reconstruction with megaprosthesis (zimmer) and tha (zimmer), and complex multilayer closure with advancement flap of rectus.Per dictation, the hemipelvectomy and tha were performed without complication.Careful attention was taken to protect the major nerves and vessels.Upon arrival to the icu, decreased pulsed were noted in the foot.Upon further examination, an area of stenosis was found in the common iliac artery.The patient was returned to the or for an embolectomy.Approximately 2 hours after the embolectomy, the patient was examined and noted to have foot fixed in plantarflexion resulting in compartment syndrome.An emergency fasciotomy was performed on the calf to release pressure.The patient then returned to the icu and remained in the hospital for over a month in recovery.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause was not 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.

• Brand Name: TM ACETABULAR REVISION SYSTEM SHIM AUGMENT 15º
• Type of Device: TM SHIM
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 6962833
• MDR Text Key: 89771597
• Report Number: 3005751028-2017-02722
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK061067
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 04/21/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 00489400115
• Device Lot Number: 62319561
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/19/2017
• Initial Date FDA Received: 10/19/2017
• Supplement Dates Manufacturer Received: 04/21/2020
• Supplement Dates FDA Received: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention