MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 ADAPTER SLEEVES 12/14 +5; HIP FEMORAL AUGMENT

Catalog Number 999800315

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Muscular Rigidity (1968); Pain (1994); Weakness (2145); Anxiety (2328); Distress (2329); Discomfort (2330); Injury (2348); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); Not Applicable (3189); No Code Available (3191)

Event Date 03/06/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).No 510(k) number provided because this implant product code was sold internationally.It was sold in the us under a different product code.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.

Event Description

Asr litigation received.Litigation alleges that the patient sustained injury, pain, stiffness, discomfort, weakness, anxiety, elevated metal ions, affects mobility, emotional distress and limited to perform normal physical activities.Doi: (b)(6) 2007; dor: (b)(6) 2018; right hip.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: this hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Udi (b)(4).H6 patient code: no code available (3191) was used to capture emotional distress and device revision or replacement.Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

After review of medical records patient was revised to addressed painful right total hip replacement metal on metal reaction, loose acetabular component and pseudotumor.The acetabular component was obviously loose and was able to remove it with simply pulling and noted some posterior bone loss with metal reaction in the acetabular socket.Metallosis and metal debris tissue was also removed.Doi: (b)(6) 2007, dor: (b)(6) 2018 right hip.

• Brand Name: ADAPTER SLEEVES 12/14 +5
• Type of Device: HIP FEMORAL AUGMENT
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 7457602
• MDR Text Key: 106399301
• Report Number: 1818910-2018-58183
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K040627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2012
• Device Catalogue Number: 999800315
• Device Lot Number: 2398210
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASR ACETABULAR CUPS 50; ASR UNI FEMORAL IMPL SIZE 45; CORAIL2 STD SIZE 8
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR