MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCREW SELF-TAPPING 6.5 MM DIA. 40 MM LENGTH; PROSTHETIC, HIP

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 11/02/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item number 00801803601, item name femoral head sterile product do not resterilize 12/14 taper, lot # 62829949.Item number 00630505036, item name liner standard 3.5 mm offset 36 mm i.D.For use with 50/52/54 mm o.D.Shells, lot # 62827799, unknown stem.The device will not be returned for analysis; due to the patient requested to have the explanted implants, however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2020-00509.

Event Description

It was reported the patient underwent a left hip procedure.Subsequently, the patient was revised due to the cup loosening approximately 5 years later.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The explanted devices were not returned for evaluation however an image was provided.The shell, screw, head and liner are pictured.The exterior of the shell shows some ingrowth debris.No further information can be identified from the provided image.Review of the device history record for the screw identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot 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 SCREW SELF-TAPPING 6.5 MM DIA. 40 MM LENGTH
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 10894906
• MDR Text Key: 217965660
• Report Number: 0002648920-2020-00510
• 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: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00625006540
• Device Lot Number: 62845858
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/08/2020
• Initial Date FDA Received: 11/24/2020
• Supplement Dates Manufacturer Received: 02/26/2021
• Supplement Dates FDA Received: 03/02/2021
• 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: 98