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

Catalog Number US157344

Device Problem Off-Label Use (1494)

Patient Problem Insufficient Information (4580)

Event Date 05/11/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-02201.D10: cat #: us157850 / m2a-magnum pf cup 50odx44id / lot #: 632540.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.

Event Description

It was reported that the patient alleges that the products were not used in the correct combination.No revision has been scheduled to date and no specific allegations against the device have been made.Attempts have been made and no further information is available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Proposed component code: mechanical (g04) - head.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Complaint was confirmed based on the evaluation of the provided invoices.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: spinal anesthesia, asa i, ebl 150ml.Legs equal in length, rom 70deg.No intraoperative complications reported.Dhr was reviewed and no discrepancies related to the reported event were found.The root cause of the reported issue is attributed to off-label usage, as the head and shell implanted are not compatible.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 additional event information to report at this time.

• Brand Name: RECAP PF HA FMRL HD RESUR 44MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17808364
• MDR Text Key: 324147625
• Report Number: 0001825034-2023-02200
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: US157344
• Device Lot Number: 452780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male