MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT28IDX48OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Catalog Number 121889148

Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problems Inflammation (1932); Itching Sensation (1943); Muscle Spasm(s) (1966); Pain (1994); Tissue Damage (2104); Joint Dislocation (2374); Not Applicable (3189); No Code Available (3191)

Event Date 02/08/2012

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Pinnacle ppf and medical records received. Pfs alleges dislocation and metallosis. After review of medical records for mdr reportability, the patient was revised to address metallosis, inflammation, and previous dislocation. Surgical notes also reported pruritus due to pain and muscle spasm. Blood work also determined that patient had high metal levels and reported that the cup was exchanged with findings of inflammation and moderate amount of dark tinged fluid with consistent metallosis and consistent pain. The patient also had an anemia of acute blood loss not necessitating transfusion. Doi: (b)(6) 2009; dor: (b)(6) 2012; left hip.

Manufacturer Narrative

After review of the medical records, it has been determined that this product has been reported twice. This duplication is an error. This report will be rejected.

• Brand Name: PINNACLE MTL INS NEUT28IDX48OD
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 5743725905
• MDR Report Key: 7506463
• MDR Text Key: 107983781
• Report Number: 1818910-2018-59372
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 02/28/2014
• Device Catalogue Number: 121889148
• Device Lot Number: 2856740
• 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: 05/14/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 03/06/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 05/11/2018 Patient Sequence Number: 1