MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT40IDX60OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Model Number 1218-87-460

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Pain (1994); Physical Asymmetry (4573); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/19/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Pinnacle medical records received. After review of medical records, patient was revised to address metallosis and loose femoral stem. During clinical visits, patient has mild leg length discrepancy, scar and pain on exam and radiographs revealed eccentrically placed metal liner. Revision notes stated that there was minimal scar, small amount of joint fluid was encountered. Fibrous tissue was removed at the cup and liner. It was mentioned that the metal ions were elevated however result shows below 7ppb. Doi: (b)(6) 2007; dor: (b)(6) 2019; (right hip).

• Brand Name: PINNACLE MTL INS NEUT40IDX60OD
• 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. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 11601984
• MDR Text Key: 243520408
• Report Number: 1818910-2021-06752
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/30/2012
• Device Model Number: 1218-87-460
• Device Catalogue Number: 121887460
• Device Lot Number: 2374113
• 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: 04/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2007
• 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: 04/01/2021 Patient Sequence Number: 1

Treatment

12/14 ARTICUL 40MM M SPEC+8.5; PINNACLE MTL INS NEUT40IDX60OD; PINNACLE SECTOR II CUP 60MM; PRODIGY LG STAT LNG RT 13.5MM