MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCR 6.5X30 SELF-TAP; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems High Blood Pressure/ Hypertension (1908); Myocardial Infarction (1969)

Event Date 01/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog number:00625006525 lot number:64175215 brand name: bone screw, catalog number: 00877502801 lot number: 2907334 brand name: biolox head, catalog number:0100102219 lot number:2937791 brand name: wagner stem, catalog number:110024463 lot number: 772480 brand name: g7 dual mobility liner , catalog number:110010244 lot number: 6362614 brand name: g7 shell, catalog number:xl-200148 lot number:140080 brand name: arcom xl head.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2019-00702.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 not returned for evaluation.

Event Description

It was reported that a patient underwent revision of left total hip arthroplasty for implant failure.Subsequently the patient was diagnosed and treated for nstemi postoperative after two days, which delayed the patients discharge.Also approximately 2 weeks post discharge experienced an isolated episode of hypertension that required an emergency room visit.Additional information was requested, however none was available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records which indicated patient was diagnosed and treated for nstemi postoperative, which delayed the patients discharge.Approximately 2 weeks post discharge patient experienced an isolated episode of hypertension that required an emergency room visit.Patient was treated and released.Device history record (dhr) 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.

Event Description

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

• Brand Name: BONE SCR 6.5X30 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: 9111600
• MDR Text Key: 159926135
• Report Number: 0002648920-2019-00701
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 00889024119826
• UDI-Public: (01)00889024119826
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• 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: 00625006530
• Device Lot Number: 64208453
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2019
• 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; Other
• Patient Weight: 50