MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX OPTION, HEAD, L, 36/+3.5, TAPER 12/14; BIOLOX OPTION HEAD/ADPT, 12/14, 36 X +3.5

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical products: liner standard 3.5 mm offset 36 mm i.D.For use with 50/52/54 mm o.D.Shells catalog# : 00630505036; lot# : 63170402, shell with cluster holes porous 56 mm o.D.Size kk for use with kk liners catalog# : 00875705601; lot# : 63719005, femoral stem beaded fullcoat 12/14 neck taper std.Body lhc size 12 12 mm distal dia.150 mm length catalog# : 00784301216; lot# : 60884463.The manufacturer received operative reports, pns for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, 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.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
Patient was implanted on the right side and underwent revision surgery due to recurrent dislocation and pain.
Additional Manufacturer Narrative
Trend analysis: no trend is identified.Event description: it was reported that the product was implanted on unknown date and revised on (b)(6) 2017 due to recurrent dislocations and pain.The patient underwent initial tha on (b)(6) 2011 and was revised for trunnionosis on unknown date.Patient had a second revision on (b)(6) 2017 due to pain and recurrent dislocations.Before the 2nd revision surgery the patient experience two dislocations on unknown dates.Review of received data: in 2011, patient had a significant arthritis of the right hip which failed conservative treatment hence it was treated with total hip arthroplasty.In 2017, another revision surgery was suggested due to recurrent disloactions and pain.Patient had earlier undergone revision for trunionosis and has had two dislocations.During surgery, a moderate amount of dark yellow joint fluid was noted upon incision of the capsule.Cultures of this were taken.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 and showed that the product combination was approved by zimmer biomet.- dhr review: the quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Conclusion summary: it was reported that the product was implanted on unknown date and revised on (b)(6) 2017 due to recurrent dislocations and pain.The patient underwent initial tha on (b)(6) 2011 and was revised for trunnionosis on unknown date.Patient had a second revision on (b)(6) 2017 due to pain and recurrent dislocations.Before the 2nd revision surgery the patient experience two dislocations on unknown dates.In vivo time of the device is unknown.The investigation results did not identify a non-conformance or a complaint out of box (coob).Based on the available information, we were not able to identify an exact root cause for this issue.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).Note: this is a split case witht warsaw complaint: (b)(4).
Event or Problem Description
Investigation results are now available.

• Brand Name: BIOLOX OPTION, HEAD, L, 36/+3.5, TAPER 12/14
• Common Device Name: BIOLOX OPTION HEAD/ADPT, 12/14, 36 X +3.5
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9688393
• Report Number: 0009613350-2020-00057
• Device Sequence Number: 14282710
• Product Code: LZO
• UDI-Device Identifier: 00889024430532
• UDI-Public: 00889024430532
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K073567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2020

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: 03/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 00-8777-036-03
• Device Lot Number: 2853561
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/12/2020
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 04/01/2020
• 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 Age: 75 YR