MAUDE Adverse Event Report: . RHK ARTICULAR SURFACE; PROSTHESIS, KNEE

Model Number N/A

Device Problems Disassembly (1168); Disconnection (1171); Unstable (1667)

Patient Problem No Information (3190)

Event Date 05/21/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: rotating hinge knee femoral component, catalog #: 00588001602, lot #: unknown, rotating hinge knee straight stem extension, catalog #: 00598801215, lot #: unknown, rotating hinge knee offset stem extension, catalog #: 00598802014, lot #: unknown, rotating hinge knee tibial component, catalog #: 00588000600, lot #: unknown.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 the patient was revised to address instability, the hinge pin disconnected and a new pin was required.No additional patient consequences were reported.

Manufacturer Narrative

The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch 3500a will be submitted.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.

Manufacturer Narrative

Concomitant medical products: femoral component; p/n: 00588001602, l/n: 62355818, stem extension straight; p/n: 00598801215, l/n: 62580985, stem extension offset; p/n: 00598802014, l/n: 62444433, tibial component precoat; p/n: 00588000600, l/n: 62500174.Pma/510(k): unknown.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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.

• Brand Name: RHK ARTICULAR SURFACE
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): .; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7340267
• MDR Text Key: 102434905
• Report Number: 0001822565-2018-01448
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 00588006014
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/06/2018
• Date Manufacturer Received: 10/03/2018
• 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
• Patient Age: 54 YR
• Patient Weight: 108