MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD MOD HD 32MM +6 NK; HIP PROTHESIS

Model Number	N/A
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Necrosis (1971); Pain (1994); Joint Dislocation (2374); Ambulation or Postural Difficulties (2544); Unequal Limb Length (4534); Swelling/ Edema (4577)
Date of Event	01/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial report: customer has confirmed that the device remains implanted.Concomitant medical devices: medical product: arcos 22x200mm cyl dist, catalog #:11-301622, lot #: unknown; medical product: arcos con sz c std 70mm, catalog #:11-301323, lot #: unknown; medical product: hooded enhanced acetabular insert size 32 mm i.D./65 mm o.D, catalog #:, 433832065, lot #: unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Devices remain implanted.
Event or Problem Description
It was reported that the patient underwent a left hip arthroplasty on an unknown date.Subsequently, a custom hip is needed for possible revision due to limb length discrepancies and patient anatomy.No revision has been reported to date.Attempts have been made but no further information has been provided at this time.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h10.Complaint summary: as the product has not been received, the investigation was limited to the information provided; a review of device history records, complaint history and x-ray review.In addition, we have not been provided with any supporting documentation which could provide additional information.Assessment of imaging: single ap film of the left hip demonstrates a left total hip arthroplasty with cement fixation of the acetabular cup.Significant bone loss along the femoral stem with possible evidence of osteolysis along the greater trochanter.Incomplete evaluation of the femoral stem.Impressions: left total hip arthroplasty with significant bone loss along the femoral stem and possible evidence of osteolysis along the greater trochanter.Overall fit and alignment of the implants is appropriate.Osteopenia with significant bone loss along the femoral stem and possible osteolysis at the level of the greater trochanter.Acetabular inclination angles cannot be accurately measured without a true ap pelvis film.However, visually, the acetabular cup appears to be in appropriate position.No anatomy abnormality that would cause limb length discrepancies a review of the manufacturing history records could not be performed as lot number is unknown.A review of the complaint database over the last 3 years has found 1 complaint reported with the item 12-115117 (initiating complaint).Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Capa: no corrective or preventive action required at this time.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.H3 other text : device remain implanted.
Event or Problem Description
It was reported that the patient underwent a left hip arthroplasty on an unknown date.Subsequently, a custom hip is needed for possible revision due to limb length discrepancies and patient anatomy.No revision has been reported to date.Attempts have been made but no further information has been provided at this time.
Event or Problem Description
It was reported that approximately two years post implantation, a revision was performed due to limb length discrepancy with custom spacer device.During the procedure noted necrotic synovial tissue, could not decouple the body from the stem due to stripping of the thread, and thin femoral bones.The head and liner were exchanged.There were past reported instances of hip dislocations.All all other implants remained in place.The patient has reported ongoing and chronic pain, swelling, and continued leg length discrepancy since the revision.The patient is now pending another custom implant due to the inability to remove the previous stem.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 corrected information.D10 - associated product: hooded enhanced acetabular insert size 32 mm i.D./65 mm o.D.; item# 433832065; lot# 62365008.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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Complaint was further investigated due to medical notes being received.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.The review identified the following points below with regards to the reported revision.Spinal anesthesia, ebl 300 ml.Previous incision utilized, encountered clear yellow fluid.Necrotic synovial tissue debrided.Cup well fixed and remained implanted.Noted stem well fixed, ball removed from body easily, attempted to remove proximal body after removing the screw, noted threads were stripped, attempted multiple times with different methods without damaging the stem or the femur, which is thinned bone.1.5 hours trying to loosen the taper of off the trunnion.¿the stem was cold welded to together and could not be disengaged¿.The custom device made was not able to be implanted due to the cold welded components.Liner and head exchanged without complications.With the available information, 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.

• Brand Name: CER BIOLOXD MOD HD 32MM +6 NK
• Common Device Name: HIP PROTHESIS
• 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: 12346760
• Report Number: 3002806535-2021-00348
• Device Sequence Number: 5130797
• Product Code: LZO
• UDI-Device Identifier: 00887868248467
• UDI-Public: (01)00887868248467(17)260630(10)673000
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051411
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/30/2023
• 2 Devices were Involved in the Event: 1 2

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: 06/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 12-115117
• Device Lot Number: 673000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 09/17/2021; 10/10/2023; 11/30/2023
• Initial Report FDA Received Date: 08/20/2021
• Supplement Report FDA Received Date: 09/21/2021; 11/06/2023; 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2016
• 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: Other; Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White