MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL HEAD 12/14 TAPER 28 MM DIAMETER +3.5 MM NECK LENGTH; PROSTHESIS, HIP

Catalog Number 802202803

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3006946279-2023-00065, 0002648920-2023-00152.G2: australia.D10: cat #: p0561e58 / avantage e1 inlay s58 / 28 / lot #: 1490803.Cat #: 00811400310 / femoral stem 12/14 neck taper ext.Offset size 3 130 mm stem length / lot #: 65270823.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 patient underwent a revision procedure post implantation due to unknown reasons.During this procedure, the original implants were removed and a spacer was implanted.It was reported that no further information is available.

Event Description

It was reported patient underwent a revision procedure post implantation due to infection.During this procedure, the original implants were removed and a spacer was implanted.It was reported that no further information is available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, implanted products are not identified as the source or contributing to the reported infection.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: FEMORAL HEAD 12/14 TAPER 28 MM DIAMETER +3.5 MM NECK LENGTH
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17306962
• MDR Text Key: 318922556
• Report Number: 0001822565-2023-01880
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024498492
• UDI-Public: (01)00889024498492(17)301031(10)3047459
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K183457
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 802202803
• Device Lot Number: 3047459
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2020
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization