MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCR 6.5X40 SELF-TAP; PROSTHESIS HIP

Model Number N/A

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

Patient Problems Bacterial Infection (1735); Post Operative Wound Infection (2446)

Event Date 02/08/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item# xl-200150, act artic hd arcom xl 28x44mm, lot# 692200.Item# 010000664, g7 pps ltd acet shell 54f, lot# 6438728.Item# 110024464, g7 dual mobility liner 44mm f, lot# 837170.Item# 00771101320, femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 13.5 extended offset, lot# 63989039.Item# 00625006530, bone scr 6.5x30 self-tap, lot# 63081166.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: 0002648920-2019-00178, 0001822565-2019-01064.

Event Description

It was reported that patient underwent hip arthroplasty revision 2 weeks post initial implantation due to infection.Patient began experiencing drainage from the incision site, beginning eight (8) days post-operatively, before the patient was diagnosed with deep wound infection.All components were removed and replaced with new components, and an extensive i&d was performed.It was noted that the cultures were (b)(6) for (b)(6), as well as (b)(6).Attempts to obtain additional information were made; however, none was available.

Event Description

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

Manufacturer Narrative

(b)(4).Udi: (b)(4).Reported event was confirmed by review of operative notes which indicated patient underwent revision of the left hip due to deep infection.Upon opening the hip, a large purulent fluid collection was identified and evacuation.The entire hip wound was debrided and all synovium, purulent fluid, purulent or necrotic tissue, and all scar tissue was removed.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 6.5X40 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: 8422386
• MDR Text Key: 138847011
• Report Number: 0002648920-2019-00179
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00625006540
• Device Lot Number: 64005644
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2019
• 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 Weight: 90