MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT POR TAPER SZ5 HI OFF; HIP FEMORAL STEM/SLEEVE

Catalog Number 157011110

Device Problems Degraded (1153); Appropriate Term/Code Not Available (3191)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Discomfort (2330); Joint Swelling (2356); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/28/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions.(b)(4).Depuy considers the investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.

Event Description

Litigation documents received.Patient underwent a revision to address pain and elevated metal ions.

Event Description

Update (b)(6) 2017 ¿medical records received.After review of the medical records for mdr reportability, in addition to what was previously reported, the revision surgery notes reported metallosis, chronic swelling, pain, and elevated metal ion levels.There was no new information that would affect the existing mdr investigation.The complaint was updated on: (b)(6) 2017.

Manufacturer Narrative

Product complaint # (b)(4).Udi (b)(4).Initial reporter occupation: lawyer.(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

After review of medical records, it was indicated that the patient had chronic swelling and pain, elevated cobalt and chromium ion levels.Serology consistent with metallosis.The patient was then revised for tha failure secondary to metallosis.Operative notes reported that there was an abundant amount of synovial fluid which with staining of the synovial tissues in anterograde fashion, which appear to be synovial tissues rather with staining gray and the joint fluid also has a graying-brownish tinged to it.There was mild amount of corrosion on the femoral neck.There was synovial cyst noted under the cup.Doi: (b)(6) 2006; dor: (b)(6) 2016; left hip.

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 SZ5 HI OFF
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6126020
• MDR Text Key: 60841811
• Report Number: 1818910-2016-32133
• 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,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/29/2017

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 Catalogue Number: 157011110
• Device Lot Number: ZL5D71000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/08/2016
• Initial Date FDA Received: 11/23/2016
• Supplement Dates Manufacturer Received: Not provided; 04/06/2021; 05/06/2021
• Supplement Dates FDA Received: 04/18/2017; 04/16/2021; 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADAPTER SLEEVES 12/14 +8; ASR ACETABULAR CUPS 58; ASR UNI FEMORAL IMPL SIZE 51
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 149