MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD MOD HD 36MM -3 NK; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: tloc 133 mp sp t1 ppsho 6x97.5, item# 51-109060, lot# 6541761.50mm o.D.Size hh porous uncemented with cluster holes shell use with hh liners, item# 00875705001, lot# 64311388.32mm i.D.Size hh neutral liner use with 50mm o.D.Size hh shell, item# 00885100932, lot# 64271009.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that patient underwent revision surgery due to pain.Patient underwent a replacement of the head component the same day as the initial total hip arthroplasty.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Event or Problem Description
It was reported that patient underwent revision surgery due to pain.Patient underwent a replacement of the head component the same day as the initial total hip arthroplasty.It is also suspected that wrong side hip was implanted.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a 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 and/or corrected information.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Device is used for treatment.The reported products were reviewed for compatibility, and it was determined that the following implants are not compatible: item#: 12-115120 desc: cer bioloxd mod hd 36mm -3 nk; item#: 00885100932 desc: 32mm i.D.Size hh neutral liner use with 50mm o.D.Size hh shell.Review of the revision invoiced product confirms that a 32mm head was subsequently implanted which is a compatible head to the 32mm i.D.Size hh neutral liner use with 50mm o.D.Size hh shell.Medical records were not provided.The root cause of the reported issue is attributed to use error - inappropriate combination of product.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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Review of the additional information 'plaintiff¿s counsel stated that the wrong 'side' hip was used in the procedure' does not affect the investigation.Review of the continuum surgical technique for the reported items confirm that the hip combination used in the surgery are not 'side' specific, i.E.Are suitable for both left or right total hip arthroplasties.Root cause remains as use error - inappropriate combination of product.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: CER BIOLOXD MOD HD 36MM -3 NK
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend
• 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: 15795596
• Report Number: 3002806535-2022-00464
• Device Sequence Number: 4674539
• Product Code: LZO
• UDI-Device Identifier: 00887868248474
• UDI-Public: (01)00887868248474(17)290115(10)2971260
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K061312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/02/2023

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: 12-115120
• Device Lot Number: 2971260
• 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: 10/20/2022
• Supplement Date Received by Manufacturer: 11/22/2022; 12/08/2022; 01/26/2023
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 12/01/2022; 01/04/2023; 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/14/2019
• 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
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female