MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RECAP PF HA FMRL HD RESUR 44MM; HIP PROSTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Urinary Retention (2119)

Event Date 06/09/2017

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 product: item # us157850, cup, lot # 815130.(b)(4).Multiple reports have been submitted for this event.Please see associated reports: 0001825034-2018-05190, 0001825034-2018-05191 - [(b)(4)].

Event Description

It was reported in a journal article, a patient experienced complications approximately 3 years following hip resurfacing arthroplasty.Patients experienced urinary retention.Patient was treated and the case was resolved within 2 days.Additional surgery was not required.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 unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies 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: RECAP PF HA FMRL HD RESUR 44MM
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7772508
• MDR Text Key: 116754732
• Report Number: 0001825034-2018-05191
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• PMA/PMN Number: PK071053
• 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: 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: US157344
• Device Lot Number: 120940
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 64