MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCR 6.5X50 SELF-TAP; HIP PROSTHESIS

Model Number N/A

Device Problems Misassembled (1398); Migration (4003)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 02/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: part: 00-7110-066-36, xlpe rev lnr 10 d 66/68/70x36, lot: 64100243.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: cup: 0001822565-2019-01141.

Event Description

It was reported that during hip surgery, the screw was driven without great force and passed through the shell without securing it.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Udi#: (b)(4).The event is confirmed with x-rays received.X-rays confirmed that the screw has pulled through the cup and is located into the acetabulum and does not secure the cup.The head of the screw appears intact.There is no evidence of fracture.Lucency is noted along the acetabular cup margins.Dhr was reviewed and no discrepancies relevant to the reported event were found.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 SCR 6.5X50 SELF-TAP
• 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
• MDR Report Key: 8434014
• MDR Text Key: 139245888
• Report Number: 0002648920-2019-00205
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K840643
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• 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: 00662406550
• Device Lot Number: 63165886
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other