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

Catalog Number 00801802803

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Fall (1848); Joint Dislocation (2374); Patient Problem/Medical Problem (2688)

Event Date 05/02/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00633405028-constrained liner-62373105 unknown-unk cup-unknown unknown-unk stem-unknown multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 00213.Product location unknown.

Event Description

It was reported the patient underwent a revision procedure approximately one year post-implantation due to recurrent dislocation.Patient experienced a fall due to unknown reasons with subsequent clunking in the right hip joint.Head and liner were revised.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.The following sections were updated/corrected updated: g4; h2; h3; h6.Reported event was confirmed by review of op notes by a health care professional.100ml of fluid encountered in the joint space, necrotic tissue again debrided from the joint.Head and liner exchanged without complication.Review of the device history records identified no related deviations or anomalies during manufacturing.Review of complaint history identified additional similar complaints for the reported items and no additional complaints for the reported part and lot combinations.It was reported that patient had a fall due to unknown reasons.However, as the reason for fall is unknown, a definitive root cause could not 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.Review of the device history records identified no related deviations or anomalies during manufacturing.

Event Description

No additional information on reported event.

• Brand Name: FEMORAL HEAD
• 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: 9607632
• MDR Text Key: 175655232
• Report Number: 0002648920-2020-00034
• 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: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 04/20/2020

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 Expiration Date: 11/30/2023
• Device Catalogue Number: 00801802803
• Device Lot Number: 62542670
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/26/2019
• Initial Date FDA Received: 01/20/2020
• Supplement Dates Manufacturer Received: 04/15/2020
• Supplement Dates FDA Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention