MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MG UNICOMPARTMENTAL KNEE SYSTEM - HEADED SCREW; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Arthritis (1723); Unspecified Infection (1930); Pain (1994); Skin Irritation (2076)

Event Date 11/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product: stemmed tibial component, catalog #: 00598004701, lot #: 63085208; articular surface, catalog #: 00599404214, lot #: 61756758; femoral component, catalog #: 00599401791, lot #: 62447562; distal femoral augment block, catalog #: 00599003710, lot #: 63138098; stem extension, catalog #: 00598801215, lot #: 62203338; posterior femoral augment block, catalog #: 00599003701, lot #: 62998902; headless screw 48mm, catalog #: 00579104200, lot #: 62565597; headless screw 48mm, catalog #: 00579104200, lot #: 63060392; stem extension, catalog #: 00598802012, lot #: 62755081.Report source: foreign: this event occurred in (b)(6).Customer has indicated product will not be returned to zimmer biomet for investigation as their policy states no products are to be returned.The investigation is in process.Once the investigation is completed, a follow-up report will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2018-00869, 0001822565-2018-06919, 0001822565-2018-06920, 0001822565-2018-06998, 0002648920-2018-00884, 0001822565-2018-07000, 0001822565-2018-07038, 0001822565-2018-07039, 0001822565-2018-07041, 0001822565-2018-07042.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.Product location unknown.

Event Description

It was reported that a patient underwent an initial left knee procedure.Subsequently, the patient underwent a revision due to infection and pain.During the procedure the soft tissue was debrided and the patient's bone was corrected.The patient's wound was irrigated with antibiotics, vacuum wound dressing was applied and the patient also had an external fixation device applied.It was noted that the cause of the infection was due to a recurrent skin infection (pseudomonas microorganism).

Event Description

Upon receipt of additional information it has been determined that this device did not cause or contribute to the reported event. the initial report was submitted in error and should be voided.

Manufacturer Narrative

Upon receipt of additional information it has been determined that this device did not cause or contribute to the reported event.The initial report was submitted in error and should be voided.

• Brand Name: MG UNICOMPARTMENTAL KNEE SYSTEM - HEADED SCREW
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8190567
• MDR Text Key: 131204099
• Report Number: 0001822565-2018-07000
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/17/2019

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 Model Number: N/A
• Device Catalogue Number: 00579104100
• Device Lot Number: 63141469
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/27/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 09/16/2019
• Supplement Dates FDA Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention