MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD OPTION HD 36MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Model Number	650-1057
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530)
Date of Event	09/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: item#:15-103203 ;lot#:565060 ;item name: taperloc microp lat fmrl 9.0mm.Item#:12-104152 ;lot#:447270 ;item name: m/h radial 3-hole shell 52mm.Item#:ep-108223 ;lot#:279030 ;item name: e-poly 36mm +3 maxrom lnr sz23.Item#:103530 ;lot#:939650 ;item name: ti low profile screw 6.5x15mm.Item#:103531 ;lot#:921530 ;item name: ti low profile screw 6.5x20mm.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Device is used for treatment.Medical records were provided and reviewed by a health care professional.Evidence of metallosis between the femoral head articulating against the metal acetabular shell.Contributing factors of event: osteopenic bone, multiple prior surgeries, hx crowe iii hip dysplasia, acetabular component noted to have excessive anteversion.With the available information, a definitive root cause cannot 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 or Problem Description
According to legal allegations, a patient who underwent an initial left total hip arthroplasty experienced acute onset of pain, limited mobility, and radiographic evidence revealed acetabular dissociation.During the subsequent revision surgery, the presence of metallosis was detected between the femoral head and the metal acetabular shell, and a broken poly liner consisting of five pieces with noticeable wear was discovered.All components, excluding the stem, were revised without any reported intraoperative complications.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Product returned; visual examination of the returned product identified that the returned ceramic head shows signs of wear with some scratching and scuffing on the outside diameter of the head.There is also some scratching on the rim of the head as well as some marks on the inside diameter of the head.Measured the overall height and width of the head and both were conforming.Review of complaint history identified additional similar complaints for the reported item and no additional similar complaints for the reported part and lot combination.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.A definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: CER BIOLOXD OPTION HD 36MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 17017987
• Report Number: 3002806535-2023-00166
• Device Sequence Number: 20620713
• Product Code: LZO
• UDI-Device Identifier: 00887868271397
• UDI-Public: (01)00887868271397(17)240211(10)130640
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K200959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/11/2024
• Device Model Number: 650-1057
• Device Catalogue Number: 650-1057
• Device Lot Number: 130640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/02/2023
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2014
• 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 H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female