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

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 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 not 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.(b)(4).
Event or Problem Description
Patient was implanted on the right side and is being monitored due to dislocation and pain.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.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
Please refer to report 0009613350-2018-01208.
Additional Manufacturer Narrative
Investigation results were made available.Concomitant medical products according d11: 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: (b)(4); lot: 2806914, yield: 100, delivered: 100, delivery date: 03.07.2015, no ncr was found, raw material certificate reviewed on: 3.12.2018.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.Ref: (b)(4); lot: 2818098, yield: 60, delivered: 58, scrapped: 2, reason for scrapping: unknown reasons, delivery date: 05.08.2015, following ncr were found: no ncr were found, 1 parts scrapped due to unknown reasons.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.Ref: (b)(4); lot: 2817991, yield: 50, delivered: 45, scrapped: 5, reason for scrapping: bore diameter is outside tolerance and outer diameter is outer tolerance, delivery date: 30.07.2015.Following ncr were found: 5 parts scrapped due to bore diameter is outside tolerance and outer diameter is outer tolerance (ncr#: 500011687, ncr#: 500012369 and ncr#: 50012630).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: despite the revision surgery occurred on (b)(6) 2016, the patient felt pains.He is admitted to emergency which suspect a 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: on (b)(6) 2016 1st revision surgery due to ceramic insert fracture on (b)(6) 2016: 1st dislocation is suspected which is captured under (b)(4).2nd dislocation occurred on (b)(6) 2016 and captured under (b)(4).3rd dislocation occurred on (b)(6) 2016 and captured under (b)(4).(this complaint) 4th dislocation occurred on (b)(6) 2016 and captured under (b)(4).On (b)(6) 2016 2nd revision surgery at the union clinic and captured under (b)(4).Devices analysis: no product was returned to zimmer biomet for in-depth analysis as the devices remain implanted.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.Conclusion summary: despite the revision surgery occurred on (b)(6) 2016, the patient felt pains.He is admitted to emergency which suspect a 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 third 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: BIOLOXDELTA CERAMIC FEMORAL HEAD M¸ 40/0, TAPER 12/14
• Common Device Name: BIOLOX DELTA HEAD
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8150035
• Report Number: 0009613350-2018-01208
• Device Sequence Number: 1552777
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 110