MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. COCR HEAD; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Discolored (1170); Material Erosion (1214); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Local Reaction (2035); Reaction (2414); Limited Mobility Of The Implanted Joint (2671)

Event Date 06/29/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown stem ¿ unknown part and lot.Unknown cup ¿ unknown part and lot.Unknown liner ¿ unknown part and lot.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 and a follow-up mdr will be submitted upon completion.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-02636.

Event Description

It was reported that patient underwent a hip revision approximately 12 years post implantation due to metallosis found at the head/neck junction.During the surgery, the and liner were removed and 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.Reported event was unable to confirmed due to limited information provided by the customer.Photos of the stem and explanted head were provided and visual review showed discoloration on the head¿s taper and stem¿s trunnion.Dhr was reviewed and no discrepancies were found.The root cause is unable to 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.

Event Description

It was reported that patient underwent a right hip revision approximately 12 years post implantation due to pain, limited and painful range of motion, elevated metal ion levels, positive mri scan, osteolysis, pseudotumor, altr, metallosis and corrosion.The head and liner were removed and replaced.Operative report notes corrosion at bottom of femoral head.Head was removed and corrosive material inside taper of the head as well on surface of trunnion was found.Osteolysis found on acetabulum.Metal was uncovered due to osteolysis.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.An updated investigation is in process and a follow-up mdr will be submitted upon completion.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 03978.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g4; h2; h6 reported event was confirmed by review of medical records noting patient underwent a revision due to failed hip arthroplasty.Radiating pain in the hip along with limited daily activities for life, and limited range of motion.Blood work revealed elevated metal ion levels and during the surgery, corrosion was found on the stems trunnion.Osteolysis was noted around the cup and psedudotumor, adverse local tissue reaction found in the joint.Additional information does not change the conclusions of the previous 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

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6: remove type of investigation code 4114 ¿ device not returned.Visual evaluation of the returned product identified scratches on the spherical surface.Taper hole shows dark foreign debris.The device was sent to sem for further analysis.The taper of the returned device corresponds to damage over the majority of the surface with severe corrosion attack and abundant corrosion debris.The additional information does not change the outcome of the previous 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

No additional event information to report at this time.

• Brand Name: COCR HEAD
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 10313428
• MDR Text Key: 200039235
• Report Number: 0002648920-2020-00352
• Device Sequence Number: 1
• Product Code: JDI
• 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: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/04/2022

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: 06/11/2018
• Device Model Number: N/A
• Device Catalogue Number: 00801803603
• Device Lot Number: 61002371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/23/2020
• Supplement Dates Manufacturer Received: 10/16/2020; 11/10/2020; 12/04/2020; 03/29/2022
• Supplement Dates FDA Received: 10/16/2020; 12/02/2020; 12/08/2020; 04/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 52 KG