MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 48MM ID US COCR LNR MM60; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 71341160

Device Problem Insufficient Information (3190)

Patient Problems Foreign Body Reaction (1868); Arthralgia (2355)

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

Device available for evaluation?: in this revision surgery, shell and stem were not explanted, while liner, femoral head and sleeve were exchanged.

Event Description

*us legal* it was reported that, after a bhr surgery in the left hip, the patient the patient experienced severe pain, limited mobility, elevated cobalt and chromium levels, pseudotumor, and metallosis.A revision surgery was performed to treat the adverse event: liner, femoral head and modular sleeve were removed.The patient outcome is unknown.

Manufacturer Narrative

H11: g4: the correct date of awareness for this adverse event is: 29-apr-2020.

• Brand Name: R3 48MM ID US COCR LNR MM60
• 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
• MDR Report Key: 10059368
• MDR Text Key: 191078697
• Report Number: 3005975929-2020-00132
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/14/2021

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
• Device Operator: No Information
• Device Expiration Date: 01/29/2019
• Device Catalogue Number: 71341160
• Device Lot Number: 09AW21347
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/27/2019
• Initial Date FDA Received: 05/14/2020
• Supplement Dates Manufacturer Received: 04/29/2020; 12/22/2020
• Supplement Dates FDA Received: 05/19/2020; 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PN 71309115. LN 10DM04298B; PN 71331860. LN 09CM08124; PN 74122548. LN 08CW16131; PN 74222300. LN 08JW19038
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR