MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. XLPE LINER; PROSTHESIS, HIP

Model Number N/A

Device Problems Difficult to Remove (1528); Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 05/10/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00620205222 ¿ trabecular metal shell ¿ 62142523, 00625006525 ¿ trilogy bone screw ¿ 62119803, 00625006525 ¿ trilogy bone screw ¿ 62188050, pha0-0268 - wright medical stem ¿ 1460123, 2600-0021 ¿ wright medical head ¿ 1462754, pi-iacl224 ¿ wright medical neck ¿ 040112327910.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.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: 0001822565 - 2017 - 02244.

Event Description

It was reported that a patient experienced pain and elevated metal ion levels.The patient underwent a right hip revision approximately 4 years post implantation.During the procedure, physician noted pseudotumor, wear and the locking ring feature appearing to be bound up.The head, neck and liner components were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: XLPE LINER
• 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
• MDR Report Key: 9250638
• MDR Text Key: 164480924
• Report Number: 0002648920-2019-00787
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K990135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 11/21/2019

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: 10/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 00631005032
• Device Lot Number: 62202336
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/07/2019
• Initial Date FDA Received: 10/29/2019
• Supplement Dates Manufacturer Received: 11/18/2019
• Supplement Dates FDA Received: 11/21/2019
• 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