MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 58G; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Myocardial Infarction (1969)

Event Date 05/23/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 01325.D10: cat# 30103607 lot# 65224087 g7 vit e neutral lnr 36mm g; cat# 650-0661 lot# 3107661 delta ceramic fem hd 36/0mm.G2: foreign: (b)(6).The customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a clinical study patient underwent a left total hip arthroplasty.Subsequently, the patient experienced a myocardial infarction 14 days postop.Attempts have been made and no further information has been provided.

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 procedural related complications are influenced by the type of surgery, patients pre-existing comorbidities, and perioperative management.Side effects of the administration of anesthesia are a known cause of chest pain, ekg changes, and myocardial infarction (heart attack) during the intraoperative and postoperative recovery.Elective total joint patients typically have a cardiac workup prior to surgery to assess the patient¿s physical readiness for surgery, hence reducing their risk for these cardiac related complications.Patients are at the highest risk immediately post op but continue to be at risk for several weeks after the procedure.As the reported complaint indicated, a cardiac postoperative complication developed two weeks postop, necessitating medical treatment to preclude further deterioration.The medical records also indicate that four cardiac stents were required which are placed due to narrowing of the vessels to treat atherosclerosis or plaque build up in the vessels which cause the narrowing and indicate underlying comorbidities prior to the procedure.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

It was reported that a clinical study patient underwent a left total hip arthroplasty.Subsequently, the patient experienced a myocardial infarction 14 days postop and underwent angioplasty with placement of 4 cardiac stents.At the next follow up two days later, the patient was doing well with no further cardiac complications.There is no additional information available at the time of this report.

• Brand Name: G7 PPS LTD ACET SHELL 58G
• 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: 17171923
• MDR Text Key: 317580338
• Report Number: 0001825034-2023-01324
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304524255
• UDI-Public: (01)00880304524255(17)320201(10)7128460
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000666
• Device Lot Number: 7128460
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/01/2022
• Initial Date FDA Received: 06/21/2023
• Supplement Dates Manufacturer Received: 06/23/2023; 06/29/2023
• Supplement Dates FDA Received: 06/27/2023; 06/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2022
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 88 KG