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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Impaired Healing (2378); Patient Problem/Medical Problem (2688)

Event Date 12/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00801803202 ¿ cocr head ¿ 60586027; 00771100610 ¿ m/l taper stem ¿ 60465143; 00620005222 ¿ trilogy shell - 60541016; 00625006530 ¿ bone screw ¿ 60601931; 00625006535 ¿ bone screw ¿ 60586310.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: 0002648920-2020-00259, 0001822565-2020-01663.

Event Description

It was reported that patient underwent a right hip revision approximately 11 years post implantation due to experiencing an open wound over the incision site.During the revision, altr was present along with evidence of corrosion with black staining layer around the trunnion as well as the inner aspect of the femoral head.The surgeon reported infection suspicions were inconclusive and the head and liner components were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records noting patient underwent a revision surgery due to open wound over the incision site.Altr was noted during the procedure along with corrosion with black staining layer around the trunnion.Cocr levels noted to have decreased, but still elevated after the procedure.Dhr was reviewed and no discrepancies were found.The root cause 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.

Event Description

No additional event information to report at this time.

• 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: 10033612
• MDR Text Key: 190173779
• Report Number: 0002648920-2020-00260
• 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: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2011
• Device Model Number: N/A
• Device Catalogue Number: 00630505032
• Device Lot Number: 60560325
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention