MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. HIP KIT; LAVAGE, JET

Catalog Number 00515048601

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/20/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation is still ongoing.Once the investigation is complete a follow up mdr will be submitted.Report source - foreign - (b)(6).

Event Description

It was reported that the part was broken and was loose that ended up in total knee replacement.

Event Description

No additional event information available.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Udi #: (b)(4).The device history record (dhr) for 00515048601 lot number z000012723, review noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.On 19 december 2018, it was reported from gelre ziekenhuis, locatie apeldoorn that the part was broken and was loose that ended up in total knee replacement.On 14 february 2019, a returned product investigation was performed on the 00515048601.The physical evaluation revealed that the device fan spray nozzle had detached from the tip.The results of the returned product investigation have confirmed the reported event.While the returned product investigation confirmed that the 00515048601 was missing the fan spray nozzle, it cannot be determined from the information provided what actually caused the fan spray nozzle to detach.Therefore, based on the information provided, a specific root cause of the reported event cannot be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

• Brand Name: HIP KIT
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8239692
• MDR Text Key: 132793201
• Report Number: 0001526350-2019-00020
• Device Sequence Number: 1
• Product Code: FQH
• 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,user facility
• Type of Report: Initial,Followup
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 00515048601
• Device Lot Number: Z000012723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other