MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX DELTA TAPER LNR JJ/36; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Model Number N/A

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

Patient Problems Failure of Implant (1924); Inflammation (1932); Pain (1994); Solid Tumour (4552)

Event Date 11/21/2023

Event Type  Injury  

Event Description

It was reported that a pseudo tumor was found on mri from a ceramic-on-ceramic hip replacement.Presents to clinic with pain anterior region of hip stem.On mri pseudo tumor visualized.The surgeon to revise implants if need be.Revision surgery is planned.The event occurred approximately 9 years post-implantation.Due diligence is in progress for this event; to date no further information has been provided.

Manufacturer Narrative

(b)(4).D10: item name: biolox delta hd 12/14 36x-3.5; ref# 000877503601; lot#2651987.Item name: cpt 12/14 stem size 1 cocr; ref#00-8114-001-00; lot#62586389.Item name: continuum tm shell clust 54 jj; ref#00-8757-054-01; lot# 62590993.Item name: trilogy bone scr 6.5x30; ref#00-6250-065-30; lot#62619015.Item name: trilogy bone scr 6.5x20; ref# 00-6250-065-20; lot#62619024.G2- united kingdom.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that patient underwent a hip revision approximately 9 years post implantation due to pseudo tumor, pain and inflammation.The stem, head and liner were removed and replaced.Attempts have been made and no additional information is available at this time.

Manufacturer Narrative

(b)(4): this follow-up report is being submitted to relay additional information.The products remain implanted; therefore, visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Review of the complaint histories found no additional related complaints for these items and the reported part and lot combinations.Medical records were not provided.With the available information, a definitive root cause could not be determined.No corrective, preventive or field action was taken following the investigation of this event.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Revision surgery was performed, however no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the complaint histories found no additional related complaints for these items and the reported part and lot combinations.With the available information, a definitive root cause could not be determined.No corrective, preventive or field action was taken following the investigation of this event.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 further event information available at the time of this report.

• Brand Name: BIOLOX DELTA TAPER LNR JJ/36
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 17866439
• MDR Text Key: 324866318
• Report Number: 0009613350-2023-00540
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024429918
• UDI-Public: (01)00889024429918(17)231130(10)2727208
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/21/2024

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: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-011-36
• Device Lot Number: 2727208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/08/2023
• Initial Date FDA Received: 10/04/2023
• Supplement Dates Manufacturer Received: 11/22/2023; 11/29/2023; 01/26/2024
• Supplement Dates FDA Received: 12/06/2023; 12/28/2023; 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2013
• 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 Outcome(s): Other; Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose