MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ZIMMER SELF TAPPING BONE SCREW; HIP PROSTHESIS

Catalog Number 00625006535

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/28/2016

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It was reported that a screw broke in half during a hip procedure and was unable to be removed.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

This report is being amended to reflect changes in model/lot #, date received by mfr, type of reports, if follow-up, what type?, evaluation codes, and additional mfr narrative.(b)(4).No device or photos were received, therefore the condition of the device is unknown.Device history record review identified no deviations or anomalies in the manufacturing process.This device is used for treatment.Complaint history search revealed no additional complaints for the part and lot combination.Surgical notes were not provided.It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.It was confirmed that the device was used in an approved and compatible combination.Relevant medical history and adherence to rehabilitation protocol are unknown.Therefore, a definitive root cause cannot be determined with the information provided.

• Brand Name: ZIMMER SELF TAPPING BONE SCREW
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5871189
• MDR Text Key: 51925983
• Report Number: 0002648920-2016-00975
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2016

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 Catalogue Number: 00625006535
• Device Lot Number: 63240741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2016
• Initial Date FDA Received: 08/12/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/18/2016; 11/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Weight: 86