MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANFACTURING GMBH BIOLOX® DELTA, CERAMIC FEMORAL HEAD, S, 36/-3.5, TAPER 12/14; BIOLOX DELTA CERAMIC FEMORAL HEADS, BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374); Ambulation or Postural Difficulties (2544); Unequal Limb Length (4534); Swelling/ Edema (4577)
Date of Event	01/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a left hip closed reduction was performed due to dislocation potentially related to the device and/or procedure.
Additional Manufacturer Narrative
Medical product: g7 osseoti 4 hole shell 54mm f; catalog#: 110010245; lot#: 65007999.G7 vit e neutral lnr 36mm f; catalog#: 30103606; lot#: 65003219.Alloclassicâ®, sl stem, offset, uncemented, 4, taper 12/14; catalog#: 01.00121.040 ; lot#: 3059915.The manufacturer did not receive x-rays, or other source documents for review.The lot number of the device was received.The device history records will be reviewed during investigation.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).The following reports are associated with this event: 0001822565-2022-00400.Remains implanted.
Event or Problem Description
No change to previously reported events.
Additional Manufacturer Narrative
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 record identified no deviations or anomalies during manufacturing.Devices are used for treatment.The reported products were reviewed for compatibility with no issues noted.Complaint history review: review of complaint history identified no additional similar complaints for the reported item and no additional complaints for the reported part and lot combination related to the event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: dislocation left hip.Er; had bilateral hip replacements 3 months ago.Today she laid back on her bed which caused her leg to dangle when she started to feel the 'sudden severe' pain to her left hip, painful pop and unable to ambulate.Tenderness, fullness, shortening of left leg, numbness, minimal distal effusion upon exam.Xray; anterior dislocation of the left hip arthroplasty.Closed reduction left total hip arthroplasty, no complications.A search was conducted in etq reliance.There are no recalls or product holds for the reported product.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: BIOLOX® DELTA, CERAMIC FEMORAL HEAD, S, 36/-3.5, TAPER 12/14
• Common Device Name: BIOLOX DELTA CERAMIC FEMORAL HEADS, BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANFACTURING 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: 13558178
• Report Number: 0009613350-2022-00098
• Device Sequence Number: 17067797
• Product Code: LZO
• UDI-Device Identifier: 00889024430358
• UDI-Public: 00889024430358
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2022

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: 00-8775-036-01
• Device Lot Number: 3073358
• 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: 01/19/2022
• Supplement Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2021
• 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
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Unknown
• Patient Weight: 82 KG