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

Model Number N/A

Device Problem Corroded (1131)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Local Reaction (2035); Tissue Damage (2104); Osteopenia/ Osteoporosis (2651)

Event Date 01/24/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00784801300 lot 61366114 kinectiv neck.00771300900 lot 61298965 kinectiv stem size 9.Unknown; unknown competitor cup unknown.Unknown; unknown competitor liner unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product location is unknown.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 - 00950.

Event Description

It was reported that the patient had an initial right total hip arthroplasty performed.The patient was revised eight years later due to pain, pseudotumors, and trunnionosis.During the revision, the zb stem, head, and neck were removed.All devices were replaced with competitor product.No additional information is available.

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.Zimmer biomet's femoral components were used in conjunction with competitor's acetabular components.Zimmer-biomet has not assessed or confirmed the compatibility of these combinations of devices, and these would be considered off-label usages of these devices.Medical records identified the following : the patient underwent an initial right total hip arthroplasty due to arthritis.Zimmer biomet's femoral components and competitor's acetabular components were implanted.The patient underwent a revision procedure due to failed hip arthroplasty.During the procedure, large amount of serosanguinous fluid was encountered.Pseudotumor and alval type reaction was observed.There was evidence of dark tissue at the head-neck region implying corrosion.No signs of dark tissue at the neck-stem interface.All zimmer biomet products - head, neck, and stem were replaced with competitor's products.Extended trochanteric osteotomy was performed to remove the stem and during the procedure, a small part of the medial calcar fractured.No other findings/ complications related to the reported event was noted.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: 10130118
• MDR Text Key: 194614013
• Report Number: 0002648920-2020-00297
• 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
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2017
• Device Model Number: N/A
• Device Catalogue Number: 00801803202
• Device Lot Number: 60785478
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/24/2020
• 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
• Patient Weight: 77