MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD STERILE PRODUCT 12/14 TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Unintended Movement (3026); Insufficient Information (3190)

Patient Problems Adhesion(s) (1695); Hematoma (1884); Loss of Range of Motion (2032); Scar Tissue (2060); Tissue Damage (2104); Joint Dislocation (2374); Patient Problem/Medical Problem (2688); No Information (3190)

Event Date 03/17/2010

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product location is unknown.The investigation is in process.Once the investigation is completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent a right hip revision approximately 3 years post implantation due to unknown reasons.The head component was removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

It was reported that the patient underwent a right hip arthroplasty and three years later the patient underwent a revision procedure due to dislocations associated with scar tissue.Scar tissue also believed to have caused device impingement and hematoma.The head component was removed and replaced.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.D11: 00620204822 shell 60577576.00771100700 stem 60683864.00625006525 bone screw 60696741.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g4; h2; h6.Reported event was unable to be confirmed due to limited information provided by the customer.Dhr was unable to be reviewed as the lot number for the device is unknown.The root cause was unable to be determined due to limited information provided by the customer.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

No additional event information to report at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Updated: b4, b5, g4, h2, h3, h6.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 01283 liner.Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Operative notes confirmed the patient was being revised for right hip dislocation.The patient had an extensive amount of scar tissue surrounding the neck and it was difficult to externally rotate the hip without getting significantly impinged.Upon dislocating the hip, there was soft tissue entrapping anteriorly.Physician noted that he felt the patient was starting to lever forward.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

No further event information available at the time of this report.

• Brand Name: FEMORAL HEAD STERILE PRODUCT 12/14 TAPER
• 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: 9750060
• MDR Text Key: 188828958
• Report Number: 0002648920-2020-00092
• 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,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2017
• Device Model Number: N/A
• Device Catalogue Number: 00801803202
• Device Lot Number: 60676199
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNK CUP.; UNK LINER.; UNK STEM.
• Patient Outcome(s): Hospitalization; Required Intervention