MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER CONSTRAINED NEUTRAL 36 MM I.D. SIZE H; PROSTHESIS, HIP

Model Number N/A

Device Problems Difficult to Insert (1316); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pulmonary Embolism (1498)

Event Date 02/08/2023

Event Type  Death  

Event Description

It was reported that the liner would not seat properly.A delay occurred that required the surgeon to cement in the patient and spend an extra 20 (twenty) minutes.The patient coded when cementing the femur and expired due to pe (pulmonary embolism).Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Concomitant medical products: cat# 110035368, lot# ax21ab1101, biomet bc r 1x40 us; cat# 110035368, lot# ax05ba1003, biomet bc r 1x40 us; cat# 110035368, lot# ax27be0212, biomet bc r 1x40 us.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No further information at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were {update/corrected} updated: g3; h2; h3; h6 no product was returned or pictures provided of the device; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot 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.

• Brand Name: LINER CONSTRAINED NEUTRAL 36 MM I.D. SIZE H
• 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: 16477277
• MDR Text Key: 310591377
• Report Number: 0001822565-2023-00569
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00889024588431
• UDI-Public: (01)00889024588431(17)270824(10)65606435
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212512
• 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,Followup
• Report Date: 03/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 30203608
• Device Lot Number: 65606435
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2022
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Death
• Patient Age: 89 YR