MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN STEM; PROSTHESIS, HIP

Model Number N/A

Device Problems Failure to Osseointegrate (1863); Separation Failure (2547)

Patient Problems Failure of Implant (1924); Necrosis (1971); Inadequate Osseointegration (2646); Muscle/Tendon Damage (4532)

Event Date 10/30/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Unknown date in 2008 or 2009.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 has been completed a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 02103 0001825034 - 2022 - 02104.

Event Description

It was reported that patient underwent a right hip revision approximately 11 or 12 years post implantation due to metal related pathology including metallosis, and elevated metal ion levels.During the procedure, inadequate osseointergration, loosening and migration of the cup, pseudocysts, necrosis and tendon damage were noted.While attempting to remove the head component, the stem easily came out at the same time and the head could not be removed.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No additional event information to report 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 h6: component code mechanical (g04) ¿ stem medical records were provided and reviewed by a health care professional.Review of the available records identified the following: very elevated cobalt-chromium level.Acetabulum appeared loose and completely rotated posterior and inferior, probable loosening of the femoral component as well.There was a huge greater trochanteric bursitis noted with multiple large pseuodocysts.There was black discoloration of the fluid and typical turbid-appearing fluid in the joint.There was only some bone integration present, approximately 1cm x 1cm-the femoral component was surprisingly easy to remove.Metallosis was an absolute finding throughout the case.Pathology taken at time of surgery verified metallosis, necrosis of the greater trochanter attachment of the abductor muscles, tear of the abductor muscles at the hip, localized tissue reaction secondary to the metallosis.Part and lot identification are necessary for review of device history records, neither were provided.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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4; b5; d9; g3; h2; h3 one m2a-magnum pf cup 54odx48id item# us157854 lot# 515440, one unk head, and one unk stem were returned and evaluated.Upon visual inspection the head and the stem were stuck together and could not be separated.There is debris on the stem.There is scuffing and scratches on the outside diameter of head.The outside diameter of the shell has missing coating and the inside radius has scratches and scuffing.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.

Event Description

No additional event information to report at this time.

• Brand Name: UNKNOWN STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15401904
• MDR Text Key: 299683431
• Report Number: 0001825034-2022-02105
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• 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: 01/19/2024
• 2 Devices were Involved in the Event: 1 2

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 Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/19/2022
• Initial Date FDA Received: 09/12/2022
• Supplement Dates Manufacturer Received: 09/19/2022; 01/18/2024
• Supplement Dates FDA Received: 09/20/2022; 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male