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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Blood Loss (2597)

Event Date 02/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog number :00625006525 lot number:64235885 brand name: bone screw, catalog number :00625006525 lot number: 64213163 brand name: bone screw, catalog number :00877502801lot number:2957999 brand name: biolox delta ceramic head, catalog number :0100101918 lot number: 2759311 brand name: wagner sl revision stem, catalog number :010000661 lot number:6395463 brand name: g7 acetabular shell, catalog number :110024461 lot number:599660 brand name: g7 dual mobility liner, catalog number : xl-200144 lot number:611390 brand name: arcom xl stem.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2019-00232.0002648920-2019-00233 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 experienced low hgb of 6.6 on post op day 2 and required blood transfusion of 1 unit.Attempts have been made and 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 operative notes identified that there was blood loss of 550 ml during the procedure.No intraoperative complications occurred.Review of progress notes identified that the patient was dizzy, and experienced low hgb of 6.6 on post op day 2.One unit of prbcs was given and patient was discharged.No further analysis could be performed with the provided medical records.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: 8452948
• MDR Text Key: 139883996
• Report Number: 0002648920-2019-00231
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• 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: 64246320
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 62