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.

• 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
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 6107428552
• 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
• Reporter Country Code: US
• PMA/PMN Number: K040627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other

Reporter Occupation

• 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

• Device Expiration Date: 06/30/2012
• Device Catalogue Number: 999800315
• Device Lot Number: 2398210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/09/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 06/12/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/25/2018 Patient Sequence Number: 1