MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ7 HI OFF; HIP FEMORAL STEM/SLEEVE

Catalog Number 157011135

Device Problems Corroded (1131); Appropriate Term/Code Not Available (3191)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Pocket Erosion (2013); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 05/30/2017

Event Type  Injury  

Manufacturer Narrative

For any product information received.This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

On may 30, 2017: litigation received.Litigation alleges pain, release of metal and metal ions into his body tissues and blood.Patient also experienced distress, anxiety and limitation of movement.Patient has not yet undergone a revision surgery, however he is in the process of having it scheduled.

Manufacturer Narrative

No device associated with this report was received for examination.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

(b)(4).

Manufacturer Narrative

Product complaint # :(b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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 the medical records the patient was revised to address adverse local soft tissue reaction secondary to large diameter metal on metal bearing tha.Patient was experiencing pain, adverse tissue reaction, elevated metal ions however lab result shows ppb is below 7.Mri also confirmed the adverse tissue reaction.Operative note reported consistent with adverse tissue reaction.Patient had a breech in the posterior capsule from which the fluid was coming.There was some corrosion debris that was present but morse taper was not affected.Patient had significant osteophyte this was removed.There was also some erosion.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: SUMMIT POR TAPER SZ7 HI OFF
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6670182
• MDR Text Key: 78485257
• Report Number: 1818910-2017-20202
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K001991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/30/2017

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2019
• Device Catalogue Number: 157011135
• Device Lot Number: DJ4A31
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/30/2017
• Initial Date FDA Received: 06/27/2017
• Supplement Dates Manufacturer Received: 07/24/2017; 01/10/2018; 01/19/2018; 09/18/2018; 09/23/2021
• Supplement Dates FDA Received: 07/25/2017; 01/19/2018; 02/09/2018; 09/24/2018; 09/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADAPTER SLEEVES 12/14 +8; ASR ACETABULAR CUPS 56; ASR UNI FEMORAL IMPL SIZE 49
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 154