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

Model Number N/A

Device Problem Component Incompatible (1108)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/30/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The following sections could not be completed due to the part/lot information could be: catalog number - 00625006530.Lot number - 63213982.Expiration date - jan 31, 2026.Manufacture date ¿ feb 12, 2016.Or the part/lot information could be: catalog number - 00625006540.Lot number - 63308798n.Expiration date - ni.Manufacture date ¿ ni.Concomitant medical products: 00620205420 63379131 shell porous with multi holes 54 mm.00631005032 63569815 liner 10 degree elevated rim 32 mm i.D.For use with 50/52/54 mm o.D.Shells.00801803203 63375195 femoral head sterile product do not resterilize 12/14 taper.00998201718 61699332 femoral stem - revision taper - nitrided cementless 17 mm diameter 185 mm stem length.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-04026.

Event Description

It was reported that during initial hip surgery, the surgeon was inserting the bone screw to secure the cup.It was reported the screw went through the cup and into the acetabulum.The screw remains implanted.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Catalog number - 00625006540; lot number - 63308798n; expiration date - jan 31, 2026; udi - (b)(4).Manufacture date ¿ feb 12, 2016.Reported event was able to be confirmed via x-ray review.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history determined that no further action is required as no trends were identified.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.

• Brand Name: BONE SCREW 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
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6946280
• MDR Text Key: 89287128
• Report Number: 0002648920-2017-00638
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK934765
• 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
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: SEE H10 NARRATIVE
• Device Lot Number: SEE H10 NARRATIVE
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2016
• 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