MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EPOLY 36MM RLC LNR MROM SZ25; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Necrosis (1971); Pain (1994); Ambulation Difficulties (2544); Metal Related Pathology (4530); Swelling/ Edema (4577)

Event Date 09/14/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: part: 16-104160, lot: 817390.Part: 51-107130, lot: 2853247.Part: 11-363665, lot: 167830.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-01838, 0001825034-2021-01840, 0001825034-2021-01841.

Event Description

It was reported that patient underwent right total hip arthroplasty approximately 5 and a half years ago.Subsequently, following chemo therapy treatments, the patient started to experience pain.Testing shows two pseudotumors in the patient's hip that will require removal as well as the implant.Revision has not yet been scheduled.Attempts have been made and no further information has been provided.

Event Description

It was reported that patient underwent right total hip arthroplasty.Subsequently, following chemo therapy treatments, the patient started to experience pain.Patient was revised for removal of a large pseudo-tumor(s) from the head of the prosthesis four (4) years post implantation.No further event information available at the time of this report.

Manufacturer Narrative

  no product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not 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

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

It was reported that patient underwent tha on right hip procedure.Patient underwent diagnostic biopsy procedure 4 years post implantation to determine if right hip mass was cancer related.Cancer was ruled out; pseudotumor was resected and necrotic tissue was identified.It was reported elevated metal ions cobalt 3.2 & chromium 0.5.No implants were removed, recommend revision procedure of hip.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.  medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues large mass noted, trouble walking, swelling, necrotic tissue, lots of metallosis, unable to free liner so removed locking ring no complications.Necrotic tissue with foci of reactive fibroblastic proliferation, chronic inflammation, 2 lymph nodes removed.Psoas tendon was sacrificed as it was circumferentially involved with the tumor, tumor was removed and reminent tissue, no gross infection noted.The additional information does not change the outcome of the initial investigation.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

It was reported that patient underwent tha on right hip procedure.Patient underwent diagnostic biopsy procedure 5 years post implantation to determine if right hip mass was cancer related.Cancer was ruled out; pseudotomor was resected and necrotic tissue was identified.No implants were removed.Subsequently, patient underwent a revision procedure 2 months later.It was relayed that elevated metal ions cobalt 3.2 & chromium 0.5.Were confirmed.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: b3; e1; e2; e3; e4; g2; g3; h2; h3; h6.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No additional information on the reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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: EPOLY 36MM RLC LNR MROM SZ25
• 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: 12023750
• MDR Text Key: 258671748
• Report Number: 0001825034-2021-01839
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100048
• 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,Followup,Followup
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2020
• Device Model Number: N/A
• Device Catalogue Number: EP-105995
• Device Lot Number: 197310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2015
• 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): Other
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White