MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL STEM 12/14 NECK TAPER STANDARD OFFSET SIZE 1 130 MM STEM LENGTH; PROSTHESIS, HIP

Model Number N/A

Device Problem Unstable (1667)

Patient Problem No Code Available (3191)

Event Date 11/05/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: 00620005622 63833276 shell; 00801803603 64484761 femoral head; 00630505636 64153745 liner.Foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation; due to the device was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 03835, 0002648920 - 2020 - 00498, 0001822565 - 2020 - 03836.

Event Description

It was reported patient underwent initial hip arthroplasty.Subsequently, the patient was revised approximately one month post implantation due to dislocation and instability.Additional information on the reported event is unavailable.

Event Description

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER STANDARD OFFSET SIZE 1 130 MM STEM LENGTH
• 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
• MDR Report Key: 10844660
• MDR Text Key: 216397565
• Report Number: 0002648920-2020-00497
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024545757
• UDI-Public: (01)00889024545757
• Combination Product (y/n): N
• PMA/PMN Number: K191735
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/17/2021

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: 00811400100
• Device Lot Number: 64631370
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/05/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 03/16/2021
• Supplement Dates FDA Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention