MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CEMENT SHIELD HINGE SERVICE KIT SIZE F PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Necrosis (1971); Pain (1994); Hypovolemia (2243)

Event Date 11/14/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4). Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-00069, 0001822565-2020-00071, 0001822565-2020-00072, 0001822565-2020-00075, 0002648920-2020-00017, 0001822565-2020-00076, 0001822565-2020-00080, and 0001822565-2020-00081. Medical devices: articular surface with segmental hinge post size f 26 mm height catalog#: 00585006026 lot#: 61036887, tibial component precoat size 3 catalog#: 00588000300 lot#: 62128962, femoral component option for cemented use only size f left catalog#: 00588001601 lot#: 60915244, tibial block and screws precoat size 4 10 mm thickness catalog#: 00598800427 lot#: 60836308, stem extension sharp fluted 15mm dia x 75mm length catalog#: 00598801515 lot#: 61798489, stem extension sharp fluted 22mm dia x 75mm length catalog#: 00598801522 lot#: 60437392, palacos rg 1x40 single catalog: 00111314001 lot: 74624301, palacos rg 1x40 single catalog: 00111314001 lot: 74624301, trabecular metal tibial half block augment tapered right lateral / left medial with screws catalog#: 00544800429 lot#: 61787914, trabecular metal femoral augment block distal only catalog#: 00549003624 lot#: 61825154. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent a knee procedure. Subsequently, around five years later, the patient was revised due to pain and aseptic loosening. During the revision, heterotopic ossification and femoral necrosis were noted.

• Brand Name: CEMENT SHIELD HINGE SERVICE KIT SIZE F
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 9559089
• MDR Text Key: 174202263
• Report Number: 0001822565-2020-00070
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070978
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 00585007516
• Device Lot Number: 62145974
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 04/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A

Patient Treatment Data

Date Received: 01/07/2020 Patient Sequence Number: 1