MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BONE SCR 6.5X30 SELF-TAP; PROSTHESIS HIP

Catalog Number 00625006530

Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Osteopenia/ Osteoporosis (2651); Insufficient Information (4580)

Event Date 01/26/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-01006 0001825034-2024-00818 0001825034-2024-00819 d10: cat #: 30103203 / g7 vit e neutral lnr 32mm c / lot #: 66394401 cat #: 010000661 / g7 pps ltd acet shell 48c / lot #: j362795 cat #: 51-107090 / tprlc 133 mp type1 pps ho 9.0 / lot #: 7498707 cat #: 650-1067 / cer option type 1 tpr sleve +3 / lot #: 3141011 cat #: 650-1056 / cer bioloxd option hd 32mm / lot #: 3165601 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 underwent a left hip procedure approximately nine days post implantation for unknown reasons.All of the items were removed and replaced.Attempts have been made and no further information is available.

Event Description

It was reported, that a patient underwent a left hip procedure.Approximately, nine days post implantation for pain and instability.All of the items were removed and replaced.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 6.5X30 SELF-TAP
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18977824
• MDR Text Key: 338587056
• Report Number: 0001822565-2024-01007
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 00889024119826
• UDI-Public: (01)00889024119826(17)330829(10)J7607604
• 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: 00625006530
• Device Lot Number: J7607604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/01/2024
• Initial Date FDA Received: 03/26/2024
• 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: 08/29/2023
• 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
• Patient Outcome(s): Required Intervention; Hospitalization