MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, ø 32/0, TAPER 12/14; HIP IMPLANT

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Unequal Limb Length (4534)
Date of Event	06/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: item #: 00771100610 femoral stem 12/14 neck taper plasma sprayed press-fit cementless.Size 6 standard offset reduced neck length -lot 62528353.Item #110010242 g7 osseoti 3 hole shell 48mm c lot-7069585.Item #30103203 32mm i.D.Size c neutral liner lot -65233890.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 will be submitted.
Event or Problem Description
It was reported that there was an initial total left hip arthroplasty which required a revision the very next day due to issues with size mismatching.Approximately 6 months post-revision the patient reported bilateral hip pain with left hip being greater than the right, and an inability to walk up or down stairs.Patient was prescribed aqua therapy but has yet to start.Approximately 2 years post-revision, the patient underwent a spinal cord surgery for unknown reasons.During a follow-up appointment for this procedure approximately 1 week later, the patient reported 100% pain relief.No further allegations have been reported.Due diligence is in progress for this complaint; to date no additional information has been received.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g3; h2; h3; h6 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of all relevant device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history identified additional similar complaints for the reported item and no additional similar complaints for the reported part and lot combination.Complaints are monitored per complaint trending process in order to identify potential adverse trends.Medical records (documentation) were provided and reviewed by health care professional; the patient complains of pain all the time.The patient has a long medical history and cannot move well in daily life and cannot use the stairs.The patient also has pain in the lumbar region (back).Medical records review: as reported by legal, initial left total hip arthroplasty performed.Subsequently, post-operative imaging demonstrated a size mismatch between the femoral head and acetabular liner implanted.As a result, a revision surgery occurred where the size 36mm head was exchanged for a size 32mm head.Six months later the patient reported bilateral hip pain with left hip being greater than the right and not being able to walk up or down stairs.Patient was prescribed aqua therapy but has reported she has yet to start due to financial reasons.Approximately 1 year and 8 months later the patient underwent a procedure for implantation of a lumbar spinal cord stimulator.9 days later, at the next follow-up appointment, the patient reports 100% pain relief.No further allegations have been reported.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.
Event or Problem Description
No additional information at this time.

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, ø 32/0, TAPER 12/14
• Common Device Name: HIP IMPLANT
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER 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: 18923541
• Report Number: 0009613350-2024-00099
• Device Sequence Number: 12627219
• Product Code: LZO
• UDI-Device Identifier: 00889024430327
• UDI-Public: (01)00889024430327(17)310617(10)3073984
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K192416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

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: 00877503202
• Device Lot Number: 3073984
• 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: 02/23/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Race: White