MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 48/54; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122154

Device Problems Patient-Device Incompatibility (2682); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Necrosis (1971); Swelling (2091); Toxicity (2333)

Event Date 01/12/2015

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed.Metallosis, necrotic tissue, pseudotumour and elevated levels of cobalt and chromium reported.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that right hip revision surgery was performed.Metallosis, necrotic tissue, pseudotumour and elevated levels of cobalt and chromium reported.The bhr cup and femoral head were replaced with a tha system from zimmer.Subsequent revision surgery was performed on (b)(6) 2015 and (b)(6) 2015 due to ongoing drainage associated with remaining metal debris particles and bone necrosis.The patient reported discomfort from 2010, which was treated with steroid injections.

• Brand Name: ACETABULAR CUP HAP SIZE 48/54
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: markus poettker ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 6899907
• MDR Text Key: 87585389
• Report Number: 3005975929-2017-00331
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2013
• Device Catalogue Number: 74122154
• Device Lot Number: 08LW19892
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2008
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD, # 74123148, LOT # 08GW17962; FEMORAL HEAD, PART AND LOT # UNKNOWN; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female