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

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical product: shell with cluster holes porous 48 mm o.D.Size gg for use with gg liners catalog no#: 00875704801 ; lot#: 61722788.Biolox delta ceramic taper liner, size gg / 32 i.D.For use with 48 mm o.D.Size gg shell catalog no#: 00877500832 ; lot#: 2597828.Femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 13.5 extended offset.Catalog no#: 00771101320 ; lot#: 61402986.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.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 is monitored due to unknown reasons.Patient had bilateral bone condensation seen on 7th year x-rays during the follow up of a clinical study.
Additional Manufacturer Narrative
Additional information was received.X-rays and surgical reports were received and will be reviewed.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
No event update.
Event or Problem Description
Note: upon investigation and receiving further information from source, bone condensation is an expected finding indicating osteointegration.There is no injury or intervention noted as a result of this finding as it is considered expected.Therefore, this complaint shall be set to not a complaint.Please delete this case from your system.
Additional Manufacturer Narrative
Investigation results were made available.Note: upon investigation and receiving further information from source, bone condensation is an expected finding indicating osteointegration.There is no injury or intervention noted as a result of this finding as it is considered expected.Therefore, this complaint shall be set to not a complaint.Please delete this case: (b)(4) from your system.

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, 32/+3.5, 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: 8168255
• Report Number: 0009613350-2018-01241
• Device Sequence Number: 1697174
• Product Code: LZO
• UDI-Device Identifier: 00889024430334
• UDI-Public: 00889024430334
• 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,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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: 01/31/2015
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-032-03
• Device Lot Number: 2524204
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 12/20/2018; 07/04/2019
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 01/15/2019; 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