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

Catalog Number 00801803601

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Necrosis (1971); Pain (1994); Joint Dislocation (2374); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

Event Date 11/26/2021

Event Type  Injury  

Event Description

It was reported a patient underwent a left hip revision approximately seven years post implantation due to recurring dislocations.During the procedure, the surgeon encountered a large amount of edema in the subcutaneous tissues, osteolysis with osteolytic tissue, and instability.The surgeon also found heterotopic bone of the acetabulum and femur, large pseudotumor with soft tissue necrosis, trunnionosis, poly wear, and metallosis throughout all the tissues.All the implants, except for the stem, were revised without further complications.Attempts have been made and no further information is available.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-03528.0002648920-2023-00296.0001822565-2023-03529.D10: cat #: 00630505036 / liner standard 3.5 mm offset 36 mm i.D.For use with 50/52/54 mm o.D.Shells / lot#: 62496977.Cat #: 00620005222 / shell porous with cluster holes 52 mm o.D./ lot #: 62481050.Cat #: 00771101200 / femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 12.5 standard offset / lot #: 62444872.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.

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.The following sections were updated/corrected updated: b4; b5; g3; h2; h3; h6 proposed component code: mechanical (g04)- head no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Dhr was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial left the was performed on (b)(6) 2014.The patient began experiencing dislocations and pain, with a revision on (b)(6) 2021.During the revision, heterotopic bone was found in the acetabulum, osteolysis and a pseudotumor, metallosis, and trunnionosis with tissue damage.All components except the stem were explanted and replaced with zb product.The complaint was confirmed based on the provided medical records.A definitive root cause cannot 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.

• Brand Name: FEMORAL HEAD 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
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18303773
• MDR Text Key: 330189477
• Report Number: 0002648920-2023-00297
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024144712
• UDI-Public: (01)00889024144712(17)231130(10)62536063
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

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: 00801803601
• Device Lot Number: 62536063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2023
• Initial Date FDA Received: 12/11/2023
• Supplement Dates Manufacturer Received: 03/15/2024
• Supplement Dates FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/24/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 103 KG