MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. SEE H10 NARRATIVE; PROSTHESIS, HIP

Model Number N/A

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

Patient Problem Blood Loss (2597)

Event Date 04/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Brand name: liner standard 3.5 mm offset 36 mm i.D.For use with 50/52/54 mm o.D.Shells.Udi: (b)(4).Concomitant medical products: item# 00620005420 shell porous with holes 54 mm o.D.Lot# 61215875; item# 00784301606 femoral stem beaded fullcoat 12/14 neck taper std.Body std.Offset size 16 16 mm distal dia.160 mm length lot# 61601513; item# 00625006525 bone scr 6.5x25 self-tap lot# 61738462; item# 00625006530 bone scr 6.5x30 self-tap lot# 61724514; item# 00877703603 biolox⮠option, head, l, 㸠36/+3.5, taper 12/14 lot# 2911123.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 00772; 0002648920 - 2019 - 00124.

Event Description

It was reported that during a revision due to infection, the patient lost 800 ml of blood intra-operatively.No additional patient consequences were reported.Antibiotic spacers were placed.Attempts were made to obtain additional information; however, none was available.

Event Description

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

Manufacturer Narrative

Upon review of the event, it has been determined that this event was a result of a coinciding procedure, and will be reported under medwatch 0002648920-2019-00119.The initial report was forwarded in error and should be voided.

• Brand Name: SEE H10 NARRATIVE
• 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: 8351377
• MDR Text Key: 136593765
• Report Number: 0002648920-2019-00123
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K002960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 03/14/2019

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 Expiration Date: 07/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00630505036
• Device Lot Number: 63721280
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/22/2019
• Initial Date FDA Received: 02/19/2019
• Supplement Dates Manufacturer Received: 03/12/2019
• Supplement Dates FDA Received: 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other