MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 46MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number 74122546

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problems Pain (1994); Rash (2033); Injury (2348)

Event Date 04/08/2018

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to increased pain and metal ion levels.

Manufacturer Narrative

It was reported that left hip revision surgery was performed due to metallosis, pain and metal ion levels.During the revision the hemi head and modular sleeve were removed.The bhr cup and femoral stem remain implanted.As of today, device return and additional information has been requested for this complaint but has not become available.Using the supplied implantation dates and hospital name.The devices part and lot numbers involved in this case have been preliminarily identified (subject to confirmation with medical records).The devices identified were as follows: 74122546, 10kw11680, hemi head 74222100, 09gw24199 modular sleeve 74120152, 13bw09400 bhr cup 71356002, 13em09201 anthology stem in the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.The available medical documents were reviewed.Based on the provided laboratory reports and the additional values provided the increased blood chromium and serum cobalt are comprehensible and above 51 ng/ml for cobalt and 50 ng/ml for chromium.Based on the systemic elevated blood metal ions a relation to the device and or a mal-function or other potential contributing factors cannot be performed.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: HEMI HEAD 46MM
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 7453412
• MDR Text Key: 106246191
• Report Number: 3005975929-2018-00127
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 00885556071588
• UDI-Public: 00885556071588
• Combination Product (y/n): N
• PMA/PMN Number: K062408
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Catalogue Number: 74122546
• Device Lot Number: 10KW11680
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETLR CUP HAP 74120152 LOT 13BW09400; ANTHOLOGY STEM 71356002 LOT 13EM09201; MODULAR SLEEVE 74222100 LOT 09GW24199; MODULAR SLEEVE, PART AND LOT # UNKNOWN; MODULAR SLEEVE, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 84