MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, ø 32/-3.5, TAPER 12/14

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: shell with cluster holes porous 48 mm o.D.Size gg for use with gg liners, catalog no#: 00-8757-048-01, lot#: 61596308.Femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 7.5 extended offset, catalog no#: 00-7711-007-20, lot#: 60976004.The manufacturer received documents for review.The manufacturer did not receive the device for investigation.Where lot numbers were received, 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 left side and experienced dislocation and was fixed by mechanical manipulation.
Additional Manufacturer Narrative
Dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trigger considering the following event is identified: dislocation event description: it was reported that the (b)(6) female patient, bmi=34.6, received biolox head/liner along with other components (legacy zb warsaw design) on (b)(6), 2011 and subsequently on (b)(6), 2017 her hip dislocated for 2nd time turning legs while sitting on a chair.The dislocation was fixed by mechanical manipulation in emergency.No surgery was performed.Review of received data: - x-rays dated (b)(6), 2011, (b)(6), 2012, (b)(6), 2013 and (b)(6), 2014 show no abnormalities regarding the positioning of the ceramic head and liner.No problems noticed.X-rays dated (b)(6), 2017 confirm the dislocated hip prosthesis.Femoral part is not located inside the acetabular socket.Same dated x-rays show also the reduced state after reduction.X-rays dated (b)(6), 2017 confirm the dislocated hip prosthesis.Femoral part is not located inside the acetabular socket.(b)(6), 2017 dated x-rays show the reduced state after reduction.Device analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: all involved devices are intended for treatment.- the compatibility check was performed and showed that the product combination was approved by zimmer biomet.- surgical technique is not reviewed as no surgical report is received to confirm whether the st was followed or not.Conclusion: patient dislocated her hip after 6 years 2 months in-vivo time during crossing/twisting her legs and subsequently her hip is reduced in emergency.The quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.The investigation results did not identify a non-conformance or a complaint out of box (coob).Received x-rays confirm the reported dislocation event.The most likely root cause for the event is the excessive movement of the patient while crossing her legs.However, an exact root cause cannot be defined with the information available at the hand.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
Please refer to report 0009613350-2018-01219.

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, ø 32/-3.5, TAPER 12/14
• Common Device Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8154661
• Report Number: 0009613350-2018-01219
• Device Sequence Number: 1770561
• Product Code: LZO
• UDI-Device Identifier: 00889024430310
• UDI-Public: 00889024430310
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K071535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2019

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: 04/30/2015
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-032-01
• Device Lot Number: 2538146
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 07/10/2019
• 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: Other
• Patient Age: 80 YR
• Patient Weight: 82