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 Unspecified Infection (1930); Blood Loss (2597)

Event Date 04/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item# 00630505036, liner standard 3.5 mm offset 36 mm i.D.For use with 50/52/54 mm o.D.Shells, lot# 63721280; 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# 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: 0002648920 -2019 -00121, 0001822565 -2019 -00768, 0002648920 -2019 -00120, 0002648920 -2019 -00119.

Event Description

Patient underwent revision due to chronic infection approximately 7 years post initial hip arthroplasty, and approximately 3 months following previous intervention due to infection.All implants were removed and spacers implanted.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of op notes which indicates patient was revised with antibiotic spacers due to left hip infection.All products were explanted.A blood loss of 800ml was noted.Spacers were implanted and desired stability was achieved.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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 during the revision, the patient experienced 800 ml of blood loss.Attempts have been made and no further information has been provided.

• 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: 8351376
• MDR Text Key: 136530131
• Report Number: 0002648920-2019-00122
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2019

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: 02/22/2021
• Device Model Number: N/A
• Device Catalogue Number: 00625006530
• Device Lot Number: 61724514
• 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; 04/09/2019
• Supplement Dates FDA Received: 03/15/2019; 04/16/2019
• 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