MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN 6.5X25MM SCREW; PROSTHESIS, HIP

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Fall (1848); Failure of Implant (1924)

Event Type  Injury  

Event Description

It was reported that the patient has been indicated for revision due to loosening of the cup after a hard fall; the patient was previously implanted with a zimmer biomet head with a depuy stem, which is not an approved use.It is unknown if that combination contributed to the event.No revision has been reported to date.No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).Catalog#: 110010263 g7 osseoti multihole 50mm d lot#: ni, unknown 6.5x35mm screw, unknown 6.5x35mm screw, unknown 6.5x35mm screw, catalog#: 11-107018 freedom constr hd 36mm t1 std lot#: ni, unknown size d neutral freedom liner, unknown depuy size 12 corail stem.Reported event was unable to be confirmed due to limited information received from the customer.Medical records were not provided.However it was noted the patient sustained a hard fall prior to the shell loosening was discovered.Device history record review was unable to be performed as the part and lot number of the device involved in the event is unknown.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-00218, 0001825034-2022-00219, 0001825034-2022-00220, 0001825034-2022-00221, 0001825034-2022-00223.

• Brand Name: UNKNOWN 6.5X25MM SCREW
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13391530
• MDR Text Key: 287188018
• Report Number: 0001825034-2022-00222
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White