MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD OPTION HD 36MM; BIOLOX DELTA CER OPT HD LG DIA

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial report: the product has been requested to be returned to zimmer biomet for an investigation.Associated products: medical product: g7 neutral e1 liner 36mm f, catalogue number: 010000858, lot number: 3464309; medical product: g7 pps ltd acet shell 54f, catalogue number: 010000664, lot number: 3509221; medical product: g7 screw 6.5mm x 25mm, catalogue number: 010000998, lot number: 3369624; medical product: cer option type 1 tpr sleve -3, catalogue number: 650-1065, lot number: 714270.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be submitted.
Event or Problem Description
It was reported, that: the patient underwent a second revision in 2017 for unknown reasons.Reopened the complaint on (b)(6) 2016 due to additional information received by legal on (b)(6) 2016.Legal counsel for the patient reported that the patient underwent an initial right total hip arthroplasty on (b)(6) 2010.Subsequently, the patient's legal counsel further reports patient was revised on (b)(6) 2015, due to patient allegations of pain, metal debris, migrated cup, metallosis, elevated metal ion levels, necrotic tissue and osteolysis.The acetabular cup, modular head and taper adapter were removed and replaced and a polyethylene liner was implanted.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.Additional information received in the operative report was that during the revision procedure, the head took approximately thirty minutes to remove.The presence of greyish black material, grey fluid with metal debris, and a lack of bony ingrowth/fibrous ingrowth around the cup was noted.The patient's legal counsel reported lab results on (b)(6) 2014, allegedly revealing a cobalt serum level of 196.1 mcg/l and a chromium serum level of 115.2 mcg/l.The patient's legal counsel reported lab results on february 5, 2015, which allegedly reveal a cobalt serum level of 148.0 mcg/l and a chromium serum level of 91.6 mcg/l.Legal counsel for the patient reported that the patient underwent an initial right total hip arthroplasty on (b)(6) 2010.Subsequently, the patient's legal counsel further reports patient was revised on (b)(6) 2015, due to patient allegations of elevated metal ion levels, pain, metal debris and a migrated cup.The acetabular cup, modular head and taper adapter were removed and replaced and a polyethylene liner was implanted.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.The patient's legal counsel reported lab results on an unknown date allegedly reveal a cobalt serum level of 196.1 mcg/l and a chromium serum level of 115.2 mcg/l.
Event or Problem Description
It was reported, that: patient underwent a second revision in 2017 due to elevated metal ion levels, migration, metallosis and pain.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay supplemental information.Complaint summary: no product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history records for item # 650-1057 lot # 638180 were reviewed for deviations and/or anomalies with no anomalies/deviations identified during manufacturing.The device is used for treatment.The reported products were reviewed for compatibility with no issues noted.The complaint history review for 650-1057 did not identify any previous complaints.Medical records were provided.The likely condition of the device when it left zimmer biomet is conforming to the specification.The reported event has not been confirmed as the product has not been returned for evaluation.The definitive root cause of the reported event cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after the investigation of this event.If any additional information is discovered or received that may adjust any conclusions or data, a supplemental report will be rendered accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: CER BIOLOXD OPTION HD 36MM
• Common Device Name: BIOLOX DELTA CER OPT HD LG DIA
• 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: 14083911
• Report Number: 3002806535-2022-00215
• Device Sequence Number: 16674505
• Product Code: LZO
• UDI-Device Identifier: 00887868271397
• UDI-Public: 00887868271397
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K192683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2022

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: Health Professional
• Device Expiration Date: 03/19/2025
• Device Model Number: N/A
• Device Catalogue Number: 650-1057
• Device Lot Number: 638180
• 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: 04/01/2022
• Supplement Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2015
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEEH10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female