FDA Adverse Event Injury Summary report: N

CONSTRAINED HEAD 12/14 TAPER 36 MM DIAMETER +0 MM

MDR report key: 18327691 · Received December 14, 2023

Report

Report Number: 0001825034-2023-02974
Event Type: Injury
Date Received: December 14, 2023
Date of Event: November 23, 2023
Report Date: December 15, 2023
Manufacturer: ZIMMER BIOMET, INC.
Product Code: LPH
PMA / PMN Number: K183457
Removal / Correction Number: N/A
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

(B)(4). D1: CONSTRAINED HEAD 12/14 TAPER 36 MM DIAMETER +0 MM NECK LENGTH FOR USE WITH FREEDOM CONSTRAINED LINERS. D10: 010000985 G7 FREEDOM CONST E1 LNR 36MM G 6771746. G2: FOREIGN: AUSTRALIA. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2023 - 02976 . CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

Additional Manufacturer Narrative · 0

UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER 1822565 ZIMMER.

Description of Event or Problem · 0

IT WAS REPORTED THE PATIENT WAS IMPLANTED WITH UNKNOWN ZIMMER BIOMET PRODUCTS. SUBSEQUENTLY, THE PATIENT WAS REVISED SEVEN MONTHS POST IMPLANTATION DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE BUT NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

Description of Event or Problem · 0

NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
261378	CONSTRAINED HEAD 12/14 TAPER 36 MM DIAMETER +0 MM	PROTHESIS, HIPS	LPH	ZIMMER BIOMET, INC.	N/A	3041611

Patients

Seq	Age	Sex	Outcome	Treatment
1	52 YR	Unknown	Required Intervention\| H