MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER 20 DEGREE ELEVATED RIM 32 MM I.D. FOR USE WITH 56 MM O.D. SHELL; PROSTHETIC, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: 00620005622 item name shell porous with cluster holes 56 mm o.D.Lot# 62747453, unknown stryker head.Multiple mdr reports were filed for this event, please see associated reports.The product has been received by zimmer biomet.The investigation is currently in process.Once the investigation has been completed, a follow-up report will be submitted.

Event Description

It was reported that the patient underwent a revision procedure due to unknown reasons.There is no additional information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Visual examination of the returned product identified lock ring returned in the lock ring groove.Bio debris embedded in the outer spherical surface.Inner spherical surface and face shows nicks and gouges.No other damage was noted for the shell.Visual review of the returned liner confirms item and lot identification.Nicks and gouges are noted to the inner and outer spherical surfaces as well as the rim.Rim and polar boss show indentation and deformation damage.Burrs are found on the rim.Pierce damage is noted through the liner sphere.No other damage was noted.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.An adequate complaint history review cannot be performed as the complication, failure mode, and/or harm experienced by the user is unknown.Medical records were not provided for this revision.It was identified that zimmer biomet devices were implanted with competitor devices.Zimmer biomet has not confirmed the compatibility for these combinations of devices.It is unknown if these off-label usages may have caused or contributed to the reported events.A definitive root cause cannot be identified.This complaint cannot be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: LINER 20 DEGREE ELEVATED RIM 32 MM I.D. FOR USE WITH 56 MM O.D. SHELL
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18073712
• MDR Text Key: 327410353
• Report Number: 0001822565-2023-03017
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 00632005632
• Device Lot Number: 62773101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/09/2023
• Initial Date FDA Received: 11/06/2023
• Supplement Dates Manufacturer Received: 02/07/2024
• Supplement Dates FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: PLEASE SEE H10
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male