MAUDE Adverse Event Report: ZIMMER BIOMET, INC. S1S HIP NECK ADAPTER -6MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Joint Dislocation (2374)

Event Date 01/16/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown spacer mold, pn unknown, ln unknown.Multiple mdr reports were filed for this event.Please see reports: 0001825034-2019-00344.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent a revision procedure due to the dislocation which was found while the drains for the previous infection were being changed.Attempts have been made and additional information on the reported event is unavailable at this time.No further information is available.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

Concomitant medical products: item # unk, unknown stem spacer mold, lot # unk, item # unk, unknown head spacer mold, lot # unk.An additional report has been submitted for this event: 0001825034-2019-02021.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event were found.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: S1S HIP NECK ADAPTER -6MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8288680
• MDR Text Key: 134463996
• Report Number: 0001825034-2019-00346
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K080979
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 431188
• Device Lot Number: 100460
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2019
• 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
• Patient Age: 60 YR