MAUDE Adverse Event Report: ZIMMER BIOMET, INC. POR FULL-CT FEM ST 13X200MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Erosion (1750); Failure of Implant (1924); Necrosis (1971); Pain (1994); Osteolysis (2377); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Swelling/ Edema (4577)

Event Date 09/23/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right total hip arthroplasty with screw fixation of the acetabular cup, no wear.No radiolucency.No fracture.Heterotopic ossification formation is present.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 03231, 0001822565 - 2021 - 02823.

Event Description

It was reported by patient¿s legal counsel reported patient underwent a right hip arthroplasty.Legal counsel further reports patient underwent a revision procedure sixteen (16) years post implantation due to unknown reasons, heterotopic ossification was identified.The femoral head was replaced.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: a2; b1; b5; b7; d1; d2; d4; d10; g3; g4; h2; h6.D10: 00801803214-femoral head +7x32mm dia ns-unknown.00620005420-trilogy fm acet shl 54 od univ-60080725.00631005032-liner 10 degree elevated rim 32 mm i.D.For use with 50/52/54 mm o.D.Shells-60148580.00625006525-bone scr 6.5x25 self-tap-60127384.00625006525-bone scr 6.5x25 self-tap-60127384.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient underwent a revision surgery approximately 15 years post implantation due to pain, swelling, elevated metal, and corrosion.During the procedure a significant amount of fluid was encountered and necrotic tissue in capsule.Iliopsoas tendon erosion and part of the greater trochanter erosion was noted as well as trunnion wear, pitting, staining, black debris.Proximal lysis at femoral stem.Stem was well fixed.A new head and sleeve were placed without any complications.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: g3; h2; h6 reported event was confirmed via medical records provided and reviewed by a health care professional.Lot identification is necessary for review of device history records; lot identification was not provided.Additional information does not change the previous root cause.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 information on the reported event.

• Brand Name: POR FULL-CT FEM ST 13X200MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12781093
• MDR Text Key: 280569539
• Report Number: 0001822565-2021-03232
• Device Sequence Number: 1
• Product Code: LPH
• 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,Followup
• Report Date: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• 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: 00784301308
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention; Hospitalization
• Patient Sex: Male