MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, XL, 36/+7, TAPER 12/14; BIOLOX DELTA CERAMIC FEMORAL HEAD

Model Number	N/A
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation.The manufacturer did not receive x-rays, or other source documents for review.The lot number of the device was received.The device history records will be reviewed during investigation.An e-mail requesting the following additional information was sent to the appropriate representatives: could you please verify and confirm reference numbers? are there any pictures available? was there a second device was available for use? was there any surgical delay at all?.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
It was reported that during the unpacking, particles were detected on the surface of the implant.
Event or Problem Description
Please refer to report 0009613350-2019-00676.
Additional 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 additional similar investigated events.Event description: during unpacking of the biolox head a discoloration, which could not be washed off, was noticed in the middle of the head, due to which the head was not used in surgery.It was reported that the head has been cleaned and autoclaved before shipping back to zimmer biomet.Review of received data: no medical data have been received due to patient privacy policy.Device analysis: visual examination: the packaging with the biolox head was returned for investigation.The package was received together with a note from the clinic saying that there was a discoloration in the middle of the head, which cannot be washed off, due to which the head was not used.The visual examination in the middle of the head showed a scratch like surface defect.Based on this visual examination the reported event can be confirmed.Review of product documentation: this device is intended for treatment.N/a, compatibility check not applicable as the device has not been used.Raw material certificate reviewed and found to be according to specification.Sterilization certificate reviewed and found to be according to specification.Conclusion: during unpacking of the biolox head a discoloration, which could not be washed off, was noticed in the middle of the head, due to which the head was not used.The visual examination confirmed the discoloration in the middle of the head.Most likely, the discoloration is a light surface defect such as a scratch or metallic smeared material on the surface of the biolox head due to contact with another material.The quality records show that all specified characteristics have met the specifications valid at the time of production.Further, the raw material certificate and the sterilization certificate of the product have been reviewed and were found to be according to specification.Due to the sterilization result and no further complaints on lot 2925762 a contamination can be excluded.The complaint history showed no similar events related to surface damages within the last 6 months prior to the event date and thereafter.The investigation results did not identify a non-conformance or a complaint out of box (coob).Based on the product and the available information the most likely root cause is a surface damage of the biolox head due to contact with another material, which may have been introduced at the supplier site, during shipment of the product from the supplier to zimmer biomet, during cleaning or packaging at zimmer biomet or during handling of the product in the or.Nevertheless, an exact root cause could not be identified.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).

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, XL, 36/+7, 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: 9314588
• Report Number: 0009613350-2019-00676
• Device Sequence Number: 607358
• Product Code: LZO
• UDI-Device Identifier: 00889024430389
• UDI-Public: 00889024430389
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-036-04
• Device Lot Number: 2925762
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 02/10/2020
• 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: Other