MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BONE SCREW SELF-TAPPING 6.5 MM DIA. 25 MM LENGTH; PROSTHETIC, HIP

Model Number N/A

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 08/21/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: 00625006525 bone screw selftapping 6.5 mm dia.25 mm length lot# j7470734 x3.110010267 g7 osseoti multihole 58mm g lot # 7196532.11-301620 arcos 20x200mm cyl dist lot #032610.11-301303 arcos con sz c std 60mm lot #632650.010000820 g7 hi-wall arcomxl lnr 36mm g lot # 6588427.11-107021 freedom constr hd 36mm t1 +9mm lot # 620700.010000985 g7 freedom const e1 lnr 36mm g lot # 7042237.G2: foreign: mexico multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2023 - 02516 0001822565 - 2023 - 02522 0001822565 - 2023 - 02521 the device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted h3 other text : device was discarded.

Event Description

It was reported that during a revision of unknown devices, the doctor noted that the acetabulum was not prepared correctly; therefore, inserted the cup with fixation of four screws.During the attempts of reduction, encountered difficulty and upon delivery of force, led to rotation of the press-fit femoral stem.A curved stem was then placed and as additional reduction attempts were made, the stem also rotated, leading to the stem being cemented.In the process of testing the hip, one event of dislocation occurred; therefore, additional reduction maneuvers were repeated.The procedure was completed and the patient was transported out of the or.After approximately 1 hour, the patient was returned to the or due to dislocation.The liner was revised to a freedom liner and was successfully reduced without dislocation.Subsequently, due to the use of tensile force, the cup detached from the acetabular wall and the patient was hospitalized hip pendent.There is no additional information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues: impressions: abnormal appearance of a right total hip arthroplasty with possible loosening of the acetabular cup and associated cement with lateral migration of the acetabular construct and femoral component.Associated hip dislocation post revision.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

There is no update to the prior event description provided.

• Brand Name: BONE SCREW SELF-TAPPING 6.5 MM DIA. 25 MM LENGTH
• Type of Device: PROSTHETIC, 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: 17744738
• MDR Text Key: 323402747
• Report Number: 0001822565-2023-02517
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024119819
• UDI-Public: (01)00889024119819(17)330304(10)J7470733
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/19/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00625006525
• Device Lot Number: J7470733
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/22/2023
• Initial Date FDA Received: 09/14/2023
• Supplement Dates Manufacturer Received: 01/17/2024
• Supplement Dates FDA Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male