MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN RING-LOC ACETABULAR SHELL; PROSTHESIS, HIP

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Mechanical Jam (2983); Naturally Worn (2988); Noise, Audible (3273)

Patient Problems Failure of Implant (1924); Pain (1994); Synovitis (2094); Joint Dislocation (2374); Metal Related Pathology (4530); Swelling/ Edema (4577)

Event Date 09/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: item number: 650-1057, item name: cer bioloxd option hd 36mm, lot #: 854430; item number: 650-1964, item name: cer option type 1 tpr sleeve -6, lot #: 834070; item number ep-108323.Item name: e-poly 36mm +3 hiwall lnr sz23.Lot#278560; item number: unknown, item name: unknown stem, lot #: unknown; item number: unknown, item name: unknown cup, lot #: unknown.The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 02395, 0001825034 - 2018 - 09879.

Event Description

It was reported patient was revised due to liner fracture, pain, noise and stiffness approximately 6 years post-implantation.During revision it was noted that the poly was fractured, the shell was cold-welded and the ceramic head was wearing on the shell.The poly, liner, and head were exchanged.Attempts have been made and no additional information is available at this time.

Manufacturer Narrative

Upon reassessment of the reported event, the cup was determined to be not reportable and did not contribute to the reported event.The disassociation and cold weld of the locking feature is attributed to fracture along the rim of the liner.The initial report was forwarded in error and should be voided.

Event Description

Upon reassessment of the reported event, the cup was determined to be not reportable and did not contribute to the reported event.The disassociation and cold weld of the locking feature is attributed to fracture along the rim of the liner.The initial report was forwarded in error and should be voided.

Event Description

It was reported patient was revised due to liner fracture, pain, noise and stiffness approximately 6 years post-implantation.During revision it was noted that the poly was fractured, the shell was cold-welded and the ceramic head was wearing on the shell.Attempts have been made and no additional information is available at this time.

Manufacturer Narrative

(b)(4).The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.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 - 2018 - 09879.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: h2; h3; h6 medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: (summarized by hcp) several pages of op notes and office notes were reviewed and confirmed the reported events acetabular wear, fractured liner, squeaking sound, ambulation, pain, noise along with others.The additional information does not change the outcome of the previous investigation.

Event Description

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

• Brand Name: UNKNOWN RING-LOC ACETABULAR SHELL
• 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: 12312287
• MDR Text Key: 266176837
• Report Number: 0001825034-2021-02395
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/18/2022

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 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: 07/29/2021
• Initial Date FDA Received: 08/12/2021
• Supplement Dates Manufacturer Received: 08/17/2021; 04/01/2022; 05/16/2022
• Supplement Dates FDA Received: 09/01/2021; 04/19/2022; 05/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: (B)(4) LOT 834070 SLEEVE.; (B)(4) LOT 854430 HEAD.; REF# UNK, TAPERLOC STEM LOT#UNK.; SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 109 KG