MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RECAP CEMENT FMRL HD RESUR 46M; HIP PROSTHESIS

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Inflammation (1932); Pain (1994); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: item # us157852, cup, lot # 926830.Multiple reports have been submitted for this event.Please see associated reports: 0001825034-2018-09457.

Event Description

It was reported that a bilateral patient was implanted with mom devices in both hips approximately 7 years ago.The patient alleges complications including pain, discomfort, inflammation, elevated ion levels, and metallosis.The patient underwent a revision surgery, however, there is no confirmation of which side was revised to date.Attempts have been made, and no further information has been provided.

Manufacturer Narrative

The product was evaluated through manufacturing review, however, the reported event could not be confirmed.The device history record were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information 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

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

Manufacturer Narrative

The received additional information does not change the root cause of the previous investigation.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: RECAP CEMENT FMRL HD RESUR 46M
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7944400
• MDR Text Key: 123059594
• Report Number: 0001825034-2018-09458
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• PMA/PMN Number: PK021799
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: N/A
• Device Catalogue Number: US157246
• Device Lot Number: 044250
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/10/2018
• Initial Date FDA Received: 10/08/2018
• Supplement Dates Manufacturer Received: 04/02/2019; 09/10/2019
• Supplement Dates FDA Received: 04/04/2019; 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability