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

Catalog Number 00625006550

Device Problem Unstable (1667)

Patient Problems Pain (1994); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00778, 0002648920-2024-00080, and 0001822565-2024-00991.D10: cat #: 110010264 / g7 osseoti multihole 52mm e / lot #: 66347196.Cat #: 00625006550 / trilogy bone scr 6.5x50 / lost #: 63033489.Cat #: 00625006525 / trilogy bone scr 6.5x25 / lot #: j7012414.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 will be submitted.

Event Description

It was reported that a patient is being scheduled for a left hip revision approximately three months post implantation due to inadequate fixation of the cup.To date, no procedure has occurred.Attempts have been made and no further information is available.

Event Description

It was reported that a patient is being scheduled for a left hip revision approximately three months post implantation due to inadequate fixation of the cup and pain.To date, no procedure has occurred.Attempts have been made and no further information is available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.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 6.5X50 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: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18967467
• MDR Text Key: 338468071
• Report Number: 0002648920-2024-00081
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024119857
• UDI-Public: (01)00889024119857(17)271130(10)63849814
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00625006550
• Device Lot Number: 63849814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 03/25/2024
• Supplement Dates Manufacturer Received: 04/08/2024
• Supplement Dates FDA Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Other