MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX OPTION, HEAD, L, 32/+3.5, TAPER 12/14; BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: item: constrained liner with constr.Ring, catalog #: 00633405832, lot #: 63221637.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 3500a will be submitted.The manufacturer did not receive x-rays, or other source documents for review.The device history records were reviewed and found to be conforming.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.(b)(4).The following reports are associated with this event: (b)(4) - (second revision).(b)(4) - (first revision).
Event or Problem Description
It was reported that the patient was implanted with biolox head.Patient subsequently underwent a revision surgery due to dislocation.
Event or Problem Description
No change to previously reported event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay updated and additional information.Event summary: it was reported that a patient experienced dislocations and underwent a second revision of the femoral head and liner on (b)(6) 2019.During the revision procedure, a large hematoma was noted, and a adductor tenotomy was performed due to an adductor it contracture limiting the patient¿s range of motion.The head and liner were exchanged without complication.Review of received data x-ray review and assessment dated on (b)(6) 2017.Revision op notes dated on (b)(6) 2019 demonstrated that the patient was revised due to dislocation.A fair amount of hematoma consistent with the prior dislocation ws noted.It should be noted that i placed the plastic locking tines rotated a little bit more superiorly since there had been some impingement on the posterior locking tine.Cup and stem well-fixed.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation this device is intended for treatment.The compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Conclusion summary: the investigation results did not identify a non-conformance or a complaint out of box (coob).The quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Revision op notes dated on (b)(6) 2019 demonstrated that the patient was revised due to dislocation.A fair amount of hematoma consistent with the prior dislocation was noted.X-ray review and assessment dated on (b)(6) 2017 demonstrated that the patient had significant lumbar spine issues with a spine to pelvis fusion which is a known risk factor for dislocation.With that current spine issue as well as his diagnosis of parkinson¿s, this certainly may be contributing significantly to his instability.Complaint could be confirmed with op notes however definitive root cause cannot be determined the need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: BIOLOX OPTION, HEAD, L, 32/+3.5, TAPER 12/14
• Common Device Name: BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8930329
• Report Number: 0009613350-2019-00526
• Device Sequence Number: 2129133
• Product Code: LZO
• UDI-Device Identifier: 00889024430495
• UDI-Public: 00889024430495
• 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: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2020

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: 03/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 00-8777-032-03
• Device Lot Number: 2804397
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 04/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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: Hospitalization; Required Intervention
• Patient Weight: 98