MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX50OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Catalog Number 121887350

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Joint Dislocation (2374); Ambulation Difficulties (2544); Joint Laxity (4526); Physical Asymmetry (4573); Swelling/ Edema (4577)

Event Date 02/15/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Revision pinnacle metal liner because of methalosis. No surgical delay. No reported product deficiency. Doi (b)(6) 2009, dor (b)(6) 2021.

• Brand Name: PINNACLE MTL INS NEUT36IDX50OD
• 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 IRELAND 9616671; st anthonys road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr; warsaw, IN 46581 ; 6107428552
• MDR Report Key: 11399817
• MDR Text Key: 234283004
• Report Number: 1818910-2021-04173
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: HR
• PMA/PMN Number: K062426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 121887350
• Device Lot Number: 3122538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A

Patient Treatment Data

Date Received: 03/02/2021 Patient Sequence Number: 1