MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX DELTA HEAD 12/14 32X0; 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	Pain (1994); Joint Dislocation (2374)
Date of Event	12/18/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent multiple dislocations resulting left total hip arthroplasty due to fifth dislocation, approximately one (1) year ten (10) months twenty two (22) days from initial surgery.Stem and shell were retained.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10 ¿ hip-unk-liner-unk item# unknown lot# unknown.Shell porous with cluster holes 54 mm o.D.Item# 00620005422 lot#62740870.Hip-unk-stem-unk item# unknown lot# unknown.G2 ¿ foreign ¿ brazil.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 by a health care professional.Review of the available records identified the following: in the spring 2018, pt dislocated while sitting and experienced pain.Underwent closed reduction with no complications.In the summer 2018, pt dislocated while sitting and experienced pain.Underwent closed reduction with no complications.In the autumn 2018, pt dislocated while in bed and experienced pain.Underwent closed reduction under anesthesia with no complications.Diagnosis of recurrent joint dislocation and subluxation.In the autumn 2019, pt dislocated while on bed and experienced pain.Confirmation of dislocation occurred "after marked flexion of hip." underwent closed reduction with no complications.Discharged with post op instructions no flexion>70 degrees, no adduct (cross knees) and crutches.In the autumn 2019, pt dislocated while leaning on balcony and turning; experienced pain.Underwent closed reduction with no complications.Surgeon notes that a revision is needed.In the winter 2019, pt underwent left hip revision, replacing the head and liner components.Diagnosis of traumatic muscle ischemia.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: 4 views of the left hip from summer 2023 through winter 2019 demonstrate a left total hip arthroplasty with standard liner.Imaging demonstrate superior dislocation of the left femoral head with possible impaction injury to the superior and lateral acetabular cup.Last image from winter 2019 demonstrates post revision of left tha with new constrained liner.The provided medical records noted "confirmation of dislocation occurred after marked flexion of hip" during the fourth dislocation event, indicating patient noncompliance as there was hyperflexion of the hip.However, it is unknown if the previous dislocations and subsequent reductions led to joint laxity and the patient being able to hyperflex it, or if there was damage to the liner from the previous closed reductions that contributed to the fourth occurrence.Therefore, a definitive root cause cannot be determined for all dislocation events.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: BIOLOX DELTA HEAD 12/14 32X0
• 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: 17222790
• Report Number: 0009613350-2023-00340
• Device Sequence Number: 17914988
• Product Code: LZO
• UDI-Device Identifier: 00889024430327
• UDI-Public: (01)00889024430327(17)270731(10)2912984
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K192416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2023

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 Model Number: N/A
• Device Catalogue Number: 00-8775-032-02
• Device Lot Number: 2912984
• 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: 06/15/2023
• Supplement Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2017
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 120 KG