MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP; PROSTHESIS HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Sepsis (2067); No Information (3190)

Event Date 10/14/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4) concomitant medical products: unknown stem, unknown femoral head.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-10099, and 0001825034-2018-10105.Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.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.

Event Description

It was reported that the patient underwent hip revision surgery due to unknown reasons.Attempts have been made and additional information on the reported event is unavailable.

Event Description

It was reported that the patient was revised approximately six years post initial surgery due to sepsis and worsening pain.No additional information available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical products : m2a magnum modular head (cat.No.157450, lot no.165290), m2a magnum taper adapter (cat.No.139256, lot no.298680), collared utegral porous stem (cat.No.170314, lot no.528690).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

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of revision op notes.The revision op notes stated that patient underwent revision of right total hip arthroplasty due to pain and blood-borne infection consistent with mssa.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.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.

Event Description

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

• Brand Name: M2A-MAGNUM PF CUP
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8054670
• MDR Text Key: 126643075
• Report Number: 0001825034-2018-10095
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K042037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2020
• Device Model Number: N/A
• Device Catalogue Number: US157856
• Device Lot Number: 365040
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention