MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX® OPTION, HEAD, S, ø 36/-3.0, TAPER 12/14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	02/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent initial left total hip arthroplasty that was subsequently revised approximately eleven (11) years later due to recurrent anterior dislocations.The patient did well until six (6) years later when she bent over and dislocated posteriorly, which was reduced in the emergency room.After recurrent dislocations following, the patient underwent a second head and liner exchange approximately seven (7) years after revision.The cup and stem were stable and left intact.A new head and constrained liner were placed without complications.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).Associated concomitant products: item reference: 00630505036, item name: liner standard 3.5 mm offset 36 mm i.D.For use with 50/52/54 mm o.D.Shells, item lot: 63165572.Investigation of this incident is currently ongoing.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 information.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 used for treatment.Medical records were provided and reviewed from an health care professional: significant past medical history: scoliosis, osteoarthritis, emphysema, hypothyroid, cataracts, rheumatoid arthritis, carpal tunnel, bilateral foot surgery.Radiographs were provided and reviewed from an radiologist.Single ap film of the pelvis and three views of the left hip all demonstrate a left total hip arthroplasty with screw fixation of the acetabular cup.Acetabular cup appears to be shallow small in size when compared to the femoral head.No radiolucency.No bony fracture seen.Well corticated ossific densities are present along the greater trochanter, nonspecific but new in the interval.Left total hip arthroplasty with undersized acetabular cup as compared to the femoral head.Interval development of multiple well corticated ossific densities along the left greater trochanter could interval prior trauma.Overall, acetabular size is small but compared to the femoral head with partial uncovering.Inclination angle of the left hip: 42° on the first set of images and 45° on the second set of images cup angle is appropriate.Sizing of the cup with respect to the femoral head does not appear to be congruent.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.

• Brand Name: BIOLOX® OPTION, HEAD, S, ø 36/-3.0, TAPER 12/14
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 16467158
• Report Number: 0009613350-2023-00101
• Device Sequence Number: 18060208
• Product Code: LZO
• UDI-Device Identifier: 00889024430518
• UDI-Public: (01)00889024430518(17)170731(10)2409183
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K073567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 00-8777-036-01
• Device Lot Number: 2409183
• 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: 02/06/2023
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2007
• 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
• Patient Weight: 50 KG
• Patient Race: White