MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCR 6.5X35 SELF-TAP; PROSTHESIS, HIP

Model Number N/A

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

Patient Problem Myocardial Infarction (1969)

Event Date 01/11/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog number: 00771100910 lot number:63994695 brand name: m/l taper stem, catalog number:00625006525 lot number:64124990 brand name: bone screw, catalog number: 00877502802 lot number: 2960402 brand name: biolox delta ceramic head, catalog number: 010000661 lot number:3442540 brand name: g7 acetabular shell, catalog number:110024461 lot number:599730 brand name: g7 dual mobility, catalog number:xl-200144 lot number: 332220 brand name: act artic hd arcom.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-02254, 0002648920-2019-00381.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.Device remains implanted in the patient.

Event Description

It was reported that the patient underwent hospitalization and a cardiac catheterization due to myocardial infarction approximately 44 days post implantation.Additional information on the reported event is unavailable at this time.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Medical records were provided and reviewed by a health care professional.Review of the available records identified that the patient underwent hospitalization and a cardiac catheterization due to myocardial infarction.Mild myocardial infarction, nausea and vomiting, per a patient report, records are limited.3 nights hospitalization, fluids and electrolytes, elective cardiac catheterization.Reported event was confirmed by review of medical records provided.Device history record was reviewed and no discrepancies were found.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.

• Brand Name: BONE SCR 6.5X35 SELF-TAP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 8653823
• MDR Text Key: 146492905
• Report Number: 0002648920-2019-00380
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• PMA/PMN Number: K934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• 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: 00625006535
• Device Lot Number: 64190171
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization
• Patient Age: 61 YR
• Patient Weight: 63