MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL POROUS WITH CLUSTER HOLES 60 MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Fall (1848); Pain (1994)

Event Date 05/04/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: zimmer liner standard 3.5 mm offset 36 mm i.D., cat#: 00630506036, lot#: 63855908.Zimmer biolox⮠delta, ceramic femoral head, m, 㸠36/0, taper 12/14, cat#: 00877503602, lot#: 2924388.Zimmer modular neck c 12/14 neck taper, cat#: 00784803300, lot#: 62141311.Zimmer kinectiv stem 13.5, cat#: 00771301300, lot#: 63759142.Zimmer screw 6.5x25mm, cat#: 00625006525, lot#: 63948927.Zimmer screw 6.5x35mm, cat#: 00625006535, lot#: 63863307.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient underwent initial left total hip arthroplasty two years ago.Subsequently, the patient was revised due to severe pain and elevated esr and sed rate following a fall.It was noted prior to the revision, the patient had a possible infection but during the revision, that was ruled out.The acetabular shell was loose with friable synovial tissue peripherally.The stem was well-fixed and left in place while all other components were replaced without complication or significant findings.No further event information is available at the time of this report.

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.Reported event was confirmed with medical records provided.Review of the medical records demonstrate the following: the patient underwent a revision procedure due to severe pain, elevated esr and sed rate following a fall.It is unknown what caused the fall.During the revision no fluid was encountered, slightly friable synovial lining tissue but no obvious infection, no components were damaged, and the acetabular component was loose.It was noted the granular type lining of the acetabulum was consistent with loosening of the cup and consistent with the lining of the synovium that was present in the joint as well.Shallow acetabulum noted and extensive irrigation was performed.The stem was well fixed and left intact, the head neck and liner were replaced without complication.Xrays were provided however they were not sent for review as the operative notes clearly indicated the complication.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause could not 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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 01903, 0002648920 - 2020 - 00341, 0002648920 - 2020 - 00342.

• Brand Name: SHELL POROUS WITH CLUSTER HOLES 60 MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10151518
• MDR Text Key: 197086469
• Report Number: 0001822565-2020-01903
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K093561
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00620206022
• Device Lot Number: 63748910
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 102