MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX® DELTA, CERAMIC FEMORAL HEAD, L, ø 40/+3.5, TAPER 12/14; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Numbness (2415)
Date of Event	04/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately three years post-implantation, the patient reports ongoing right hip pain and numbness from hip to foot.Another revision is being planned but it is unknown if a revision has been scheduled to date.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).D10: item # 00992307845, xl body nitrided cementless, lot # 64013976.Item # 00998209902, nut compression cementless, lot # 63855103.Unknown item #, unknown stryker cup, lot # ljr382 unknown item #, unknown cement depuy, lot # 9577992.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.No product was provided to the product surveillance team for further investigation or review, and no photographs of the affected devices were included.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Medical records were provided and reviewed by a health care professional.The patient is a male born in 1958, is 183cm and 113kg (bmi 33.8).The patient underwent surgery for the removal of a plating system and implantation of a total hip replacement system on the right leg.During this surgery, zimmer biomet products were implanted.After approximately 10 years post initial implantation, the patient fell and sustained an injury to the right hip at an old surgical incision site, which subsequently developed into an open, draining abscess.After several unsuccessful aspiration attempts, the condition progressed, necessitating the full explantation of the hip system during the year following the fall, due to joint infection.During this surgery, a cement mixed with antibiotics was implanted as a spacer, as well as new zimmer biomet products together with competitor products (cement from depuy and cup from stryker).After approximately 13 years and 7 months post initial implantation, the patient reported persistent right hip pain and numbness extending from the hip to the foot, with plans underway for another revision surgery.Additionally, the patient underwent a left tha, and a metal-on metal hip system from zimmer biomet was implanted.After approximately 3 years and 4 months, the implant was revised due to loosening.The provided documentation indicate that the patient has pre-existing comorbidities, including chronic pain syndrome and lumbar spinal stenosis.However, no supporting medical records were provided.The patient has pre-existing comorbidities, including chronic pain syndrome and lumbar spinal stenosis.These conditions can cause symptoms such as radiating pain, weakness, and numbness, which align with the patient¿s reported experiences.Additionally, it was determined that zimmer biomet has not approved the application and combination of the implanted devices.It is unknown if this off-label use caused or contributed to the reported event.In conclusion, since the cause may be multifactorial, consisting of patient- and procedure-related factors, a definitive root cause could not be identified.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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b3, b4, b5, d6b, g3, g6, h2, h6, h11.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 or Problem Description
Patient underwent right tha after removal of plating system due to prior trauma fracture and later, the patient developed pain and limping approximately 8 years post implantation and continued, was treated conservatively.Approximately 10 years post implantation the patient fell and sustained an injury to right hip old incisional site that progressed into an open and draining abscess above.Several unsuccessful aspirate attempts, then lead to full explant and spacer implantation due to joint infection approximately 11 years post implantation.Approximately 14 years and 8 months post implantation underwent the second stage of the revision where loosening of the competitor cemented acetabular cup was found and all implants except for the stem were revised without complication.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No additional event information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h11 medical records were provided and reviewed by a health care professional.On (b)(6) 2025, the post-operative status: pain and aseptic loosening of the cemented acetabular component (competitor implant).Spinal anesthesia was used.Standard posterior approach.No obvious signs of infection were observed; frozen section samples were negative.The cemented cup was removed with little to no bone loss.The posterior capsule and short external rotators were deficient, but they were repaired to the back of the femur using drill holes.No intra-operative complications or events occurred.The team believes that posterior hip precautions will be necessary, given the multiple previous surgical approaches.The previously reported investigation conclusion still stands.

• Brand Name: BIOLOX® DELTA, CERAMIC FEMORAL HEAD, L, ø 40/+3.5, TAPER 12/14
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 19665118
• Report Number: 0009613350-2024-00259
• Device Sequence Number: 6745361
• Product Code: LZO
• UDI-Device Identifier: 00889024430419
• UDI-Public: (01)00889024430419(17)281031(10)2965104
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K192416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/18/2025

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
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00877504003
• Device Lot Number: 2965104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 12/12/2024; 06/24/2025; 12/12/2025
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 12/13/2024; 07/18/2025; 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 113 KG