MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FREEDOM RINGLOC CONSTRAINED LINER; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problem Ossification (1428)

Event Date 05/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown, unknown stryker cup, unknown.A 11-107020 freedom constr hd 36mm t1 +6mm 505340.A 11-300817 arcos 17x150mm spl tpr dist 146970.A 11-301301 arcos con sz a std 60mm 499400.The complaint was confirmed based on the x-rays that were provided.X-ray review shows asymmetric position of the femoral head within the acetabular cup.Review of the device history record identified no deviations or anomalies.A non-zimmer biomet implant stryker cup was used with the reported biomet components liner, head & stem.Zimmer- biomet has not confirmed the compatibility of this combination of devices, and this would be considered an off-label use of this product.However, it cannot be confirmed that this incompatibility has any definitive relationship to the reported event.Hence, the root cause of the reported issue 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-03656, 0001825034-2018-03654.

Event Description

It was reported in an x-ray review that there was asymmetric positioning of the femoral head within the acetabular cup, indicating possible polyethylene liner wear following a right total hip revision procedure.Lucency of the proximal femur and heterotopic ossification along the lateral hip were also noted.No other information is available.

• Brand Name: FREEDOM RINGLOC CONSTRAINED LINER
• 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: 7546137
• MDR Text Key: 109359032
• Report Number: 0001825034-2018-03652
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK030047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 11-107022
• Device Lot Number: 423940
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2015
• 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 Age: 83 YR
• Patient Weight: 68