MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOLOX DELTA HEAD 36 MM 12/14 L / +8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED, UNCEMENTED

Catalog Number	76539167
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/25/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent right hip revision surgery due to instability.Acetabular liner and femoral head were replaced.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, according to the provided implantation report, a posterior incision was used for the surgery.A review of the provided revision report indicates that the source of the instability was an inadequate posterior support with flexion and internal rotation, the implants well fixed, the +4 head was replaced by a +12 head of same size and the liner was replaced to a 20° lateralized liner.No information about the implant position was provided.No information about the cause of the inadequate posterior support was provided.Whether implant position or patient specific anatomy caused the instability remains unknown.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: BIOLOX DELTA HEAD 36 MM 12/14 L / +8
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED, UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7154030
• Report Number: 1020279-2017-01357
• Device Sequence Number: 1496963
• Product Code: LZO
• UDI-Device Identifier: 03596010566973
• UDI-Public: 03596010566973
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2018

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 Expiration Date: 07/29/2023
• Device Catalogue Number: 76539167
• Device Lot Number: 13GT32814
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/25/2017
• Supplement Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 12/29/2017
• Supplement Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: R3 0DEG+4 XLPE ACET LNR 36X54MM,71336954/14AM22083
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR