MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA CERAMIC FEMORAL HEAD M 40/0, TAPER 12/14

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/24/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical product : avenir, stem, standard, cemented, 5, taper 12/14 catalog #: 0106010205 ; lot #: 2818098, allofit it alloclassic shell for acetabulum, uncemented, 56/kk catalog #: 00875505600; lot #: 2817991.The manufacturer did receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the explanted 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 medical intervention due to dislocation and pain.
Event or Problem Description
Please refer to report 0009613350-2018-01198.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.Additional and corrected information are filled in the following fields: additional: weight - common device name - uf follow up, what type? correction: date of report - other relevant history - pma/510(k) - adverse event - additional mfg narrative.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 cmp-(b)(4).
Additional Manufacturer Narrative
Investigation results were made available.Additional: correction: d11 - medical product: item: unknown pe insert item#: unknown lot#: unknown item: avenir, stem, standard, cemented, 5, taper 12/14 item#: 0106010205 lot#: 2818098 item: allofit it alloclassic, shell for acetabulum, uncem.56/kk item#: 00875505600 lot#:2817991.As the case at hand is a legal claim it is not suspected that the devices or additional information are being submitted for review.Zimmer gmbh winterthur legal department have already passed all information that was received from the lawyer, to our complaint handling department.By experience zimmer gmbh never gets more information except for the one that has been already covered in the final report.Patients¿ advocates only provide to zimmer gmbh as much information as they are willing to share to protect the rights of their clients.All information which has been provided for this particular case is already covered in the final report.Nevertheless, should additional information become available to us, a follow up report will be submitted.A technical investigation was not possible to be performed, as the device(s) were not at hand for investigation.However, based on the available information the investigation is conducted with outcome as follows.Dhr review: ref:00-8775-040-02 ; lot:2806914 - yield: (b)(4) - delivered:(b)(4) the device manufacturing quality records indicate that the released components met all requirements to perform as intended ref:0106010205 ; lot:2818098 - yield:(b)(4) - delivered:(b)(4) - scrapped:2 - reason for scrapping: unknown reasons the device manufacturing quality records indicate that the released components met all requirements to perform as intended ref: 00-8755056-00; lot:2817991 - yield:(b)(4) - delivered:(b)(4) - scrapped:5 - reason for scrapping:bore diameter is outside tolerance and outer diameter is outer tolerance the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: a trigger considering the following event is identified: dislocation event description: it was reported that despite the revision surgery done on (b)(6) 2016, the patient felt pains.He is admitted to emergency which suspect dislocation of the hip prosthesis.Review of received data some legal documentation and patient visit reports were received (in french).The legal documentation mentions that the patient had 4 times dislocation within 5 months.All these dislocations were occurred after the first revision surgery done on (b)(6) 2016.No other relevant information in the legal documentation.The patient visit reports show that on (b)(6) 2016 during a medical consultation presence of foreign body was noticed: two metal splinters seen on x-rays, which were not seen post-operatively.On (b)(6) 2016 those foreign bodies seemed to belong to the insert which had migrated; a loss of thickness of the implant (compared to x-rays) is also noticed / mentioned.No anomalies in the interface between bone and cup were seen.Soft tissue with these fragments was taken to analyses.It is also noted that the patient had always pain after the first revision surgery and therefore got some painkiller.This patient had the initial surgery on (b)(6) 2015.After that time the patient had 2 revision surgeries and 4 times dislocation.See below the summary: (b)(6) 2016 1st revision surgery due to ceramic insert fracture (b)(6) 2016: 1st dislocation is suspected which is captured under (b)(4) (this complaint); 2nd dislocation occurred on (b)(6) 2016 and captured under (b)(4); 3rd dislocation occurred (b)(6) 2016 and captured under (b)(4); 4th dislocation occurred (b)(6) 2016 and captured under (b)(4) (b)(6) 2016 2nd revision surgery at the (b)(6) and captured under (b)(4) devices analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: this device is intended for treatment./ all involved devices are intended for treatment.The compatibility check was performed and showed that the product combination was approved by zimmer biomet.Conclusion summary it was reported that despite the revision surgery done on (b)(6) 2016, the patient felt pains.He is admitted to emergency which suspect dislocation of the hip prosthesis.Some legal documentation and patient related reports were received (in french).These documents show that the patient had 2 revision surgeries and 4 dislocations within 5 months.In total 6 complaints were created for this patient.This complaint is for the first dislocation.Neither x-rays nor devices or photos of the explanted implants were received; therefore the condition of the components is unknown.The investigation results did not identify a non-conformance or a complaint out of box (coob).However, based on the given information and the results of the investigation, we were not able to identify a specific 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: the following report is associated with this event (same patient): (b)(4).
Event or Problem Description
Investigation results are now available.

• Brand Name: BIOLOX DELTA CERAMIC FEMORAL HEAD M 40/0, 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: 8149898
• Report Number: 0009613350-2018-01198
• Device Sequence Number: 18893112
• Product Code: LZO
• UDI-Device Identifier: 00889024430402
• UDI-Public: 00889024430402
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K071535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/05/2019

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: 05/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-040-02
• Device Lot Number: 2806914
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 03/29/2019; 07/02/2019
• Initial Report FDA Received Date: 12/11/2018
• Supplement Report FDA Received Date: 04/16/2019; 07/05/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE; SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 110