MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD STERILE PRODUCT; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); No Information (3190)

Event Date 12/02/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis as location is unknown; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 00166.

Event Description

It was reported by patients¿ legal counsel that the patient underwent a left hip revision procedure approximately nine years and five months post initial implantation.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D11: zimmer m/l taper femoral stem (00-7711-007-00, 60894782); zimmer versys femoral head -3.5 (00-8018-032-01, 60975943); zimmer tm modular acetabular shell (00-6202-054-22, 60961728); zimmer trilogy acetabular liner (00-6310-050-32, 60666550).

Event Description

It was reported the patient underwent left total hip arthroplasty.Subsequently a revision was performed approximately 11 years later due to pain, elevated metal ions, and corrosion.The femoral head was revised.No further event information available at the time of this report.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined this is a duplicate of (b)(4).All information will be reported under (b)(4).The initial report was forwarded in error and should be voided.

Event Description

Upon reassessment of the reported event, it was determined this is a duplicate of (b)(4).All information will be reported under (b)(4).The initial report was forwarded in error and should be voided.

• Brand Name: FEMORAL HEAD STERILE PRODUCT
• 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: 11171876
• MDR Text Key: 226858584
• Report Number: 0002648920-2021-00009
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K953337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2021

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: 00801803201
• Device Lot Number: 60975943
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 01/11/2021; 04/28/2021
• Supplement Dates FDA Received: 02/02/2021; 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 96