MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ZIMMER LINER; HIP PROSTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Antibiotics, Reaction To (1713); Renal Failure (2041)

Event Date 08/07/2014

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 remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: item # unk, hip-unknown-heads-unk, lot # unk.Item # 00771101500, femoral stem, lot # 61170469.Item # 00620205422, cup, lot # 611257414.Item # 00620105400, locking ring, lot # 62628006.Legal notification.Multiple reports have been submitted for this event.Please see associated reports: 0001822565-2018-02365.

Event Description

It was reported that a patient¿s creatinine began to rise and subsequently went into kidney failure approximately 3 weeks post revision surgery due to infection.Patient was admitted to the nephrology unit for one week, and was diagnosed with acute interstitial nephritis secondary to antibiotic therapy received post revision surgery.Patient has no history of renal dysfunction.Attempts have been made, and no further information has been provided.

Manufacturer Narrative

This report is being submitted to relay additional information.Reported event was confirmed by review of medical records.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: UNKNOWN ZIMMER LINER
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7460477
• MDR Text Key: 106516702
• Report Number: 0001822565-2018-02364
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 07/10/2018

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?: No
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/30/2018
• Initial Date FDA Received: 04/25/2018
• Supplement Dates Manufacturer Received: 07/06/2018
• Supplement Dates FDA Received: 08/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR
• Patient Weight: 93