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

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Date 03/18/2019

Event Type  Injury  

Manufacturer Narrative

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.Device history record (dhr) was reviewed and no discrepancies were found 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).Discarded by hospital.

Event Description

It was reported that the patient underwent a revision surgery due to implant loosening.Attempts to obtain additional information have been made; however, no more is available.

Event Description

Please refer to report 0009613350-2019-00213.

Manufacturer Narrative

This follow-up report is being filled to relay investigation result.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: subluxation.Event description: it was reported that patient underwent an initial left thr surgery on (b)(6) 2013 and revised on (b)(6) 2015 in which the biolox delta head was implanted.Finally, it was explanted on (b)(6) 2019 due to loosening.Surgeon stated that the tension on the ceramic head and the socket was loose, not devices.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Device analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: this device is intended for treatment.Compatibility: compatibility check could not be performed as only one product had been reported.Surgical technique is not reviewed as no surgical report was received to compare whether the surgical technique was followed or not.Conclusion: review of the device history records for the product did not identify any deviations or anomalies related to the reported event.The investigation results did not identify a non-conformance or a complaint out of box (coob).Neither x-rays, operative notes, office visit notes, nor devices or photos of the explanted implant was received.Patient factors that may affect the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), soft tissue laxity and relevant medical history are unknown.Adherence to rehabilitation protocol is unknown.Other components of the thr system are also unknown.Therefore, in the absence of required medical data the complaint could not be confirmed.In conclusion, due to significant lack of information, it is impossible to perform a meaningful analysis of the reported event.Therefore, an exact root cause cannot be determined.However, the most likely reason is increased soft tissue laxity since the doctor stated that the head/cup connection is loose and not the devices.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)(6).

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, ø 32/+3.5, TAPER 12/14
• Type of Device: BIOLOX DELTA CERAMIC FEMORAL HEAD
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8507623
• MDR Text Key: 141733024
• Report Number: 0009613350-2019-00213
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024430334
• UDI-Public: 00889024430334
• Combination Product (y/n): N
• PMA/PMN Number: K071535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/10/2019

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-032-03
• Device Lot Number: 2728636
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/18/2019
• Initial Date FDA Received: 04/12/2019
• Supplement Dates Manufacturer Received: 10/04/2019
• Supplement Dates FDA Received: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 41 YR