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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure of Implant (1924)

Event Date 08/25/2014

Event Type  Injury  

Event Description

It was reported that patient underwent right hip revision surgery due to instability.Acetabular liner and femoral head were replaced.

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
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED, UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: markus poettker ; schachenallee 29; aarau 05001 ; SZ 05001
• MDR Report Key: 7154030
• MDR Text Key: 96024173
• Report Number: 1020279-2017-01357
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 03596010566973
• UDI-Public: 03596010566973
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083762
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2023
• Device Catalogue Number: 76539167
• Device Lot Number: 13GT32814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/25/2017
• Initial Date FDA Received: 12/29/2017
• Supplement Dates Manufacturer Received: 09/25/2017
• Supplement Dates FDA Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/31/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: R3 0DEG+4 XLPE ACET LNR 36X54MM,71336954/14AM22083
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR