MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ORTHOPEDIC SALVAGE SYSTEM RS POLYETHYLENE FEMORAL BUSHINGS PROSTHESIS, KNEE

Model Number N/A

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

Patient Problem Blood Loss (2597)

Event Date 12/07/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4). Concomitant medical devices ¿ orthopedic salvage system modular tibial baseplate 67mm, catalog #: 15042,1 lot #: 523710; orthopedic salvage system tibial augment block 10 x 63/67mm, catalog #: 150426, lot #: 225600; orthopedic salvage system cemented proximal tibial stem, catalog #: 150445, lot #: 751190; orthopedic salvage system 5cm reinforced yolk, catalog #: 150493, lot #: 065310; orthopedic salvage system polyethylene tibial bushing, catalog #: 150476, lot #: 248130; orthopedic salvage system rs axle, catalog #: 161035, lot #: 257570; orthopedic salvage system polyethylene locking pin, catalog #: 150510, lot #: 211820; orthopedic salvage system cemented im stem 13mm x 225mm, catalog #: 150374, lot #: 416160; orthopedic salvage system diaphyseal locking screw set, catalog #: 150481, lot #: 583850; orthopedic salvage system 4cm diaphyseal segment, catalog #: 150482, lot #: 034700; orthopedic salvage system segmental stacking adapter, catalog #: 150483, lot #: 097170; orthopedic salvage system 4cm diaphyseal segment, catalog #: 150482, lot #: 899920, orthopedic salvage system rs 7cm modular segmented femoral component right catalog #: 161011, lot #: 306670; orthopedic salvage system polyethylene tibial bearing 16mm, catalog #: 150412, lot #: 790410. The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as it still remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001825034-2019-00696, 0001825034-2019-00697, 0001825034-2019-00698, 0001825034-2019-00699, 0001825034-2019-00700, 0001825034-2019-00702, 0001825034-2019-00703, 0001825034-2019-00704, 0001825034-2019-00705, 0001825034-2019-00706, 0001825034-2019-00707, 0001825034-2019-00708, 0001825034-2019-00709, 0001825034-2019-00710. Device evaluated by mfr? investigation incomplete.

Event Description

It is reported that during the patient¿s post-operative stay for knee arthroplasty, the patient experienced low hemoglobin and hematocrit levels and required a blood transfusion for post-operative anemia. No additional patient consequences were reported.

• Brand Name: ORTHOPEDIC SALVAGE SYSTEM RS POLYETHYLENE FEMORAL BUSHINGS
• 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: 8348416
• MDR Text Key: 136488584
• Report Number: 0001825034-2019-00701
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021260
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 161034
• Device Lot Number: 261210
• 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: 11/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2018
• 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: 02/18/2019 Patient Sequence Number: 1