MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 60MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-22-060

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

(b)(6) 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).

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 material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: PINNACLE SECTOR II CUP 60MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11602026
• MDR Text Key: 243543320
• Report Number: 1818910-2021-06754
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295009863
• UDI-Public: 10603295009863
• Combination Product (y/n): N
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• 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: No Information
• Device Model Number: 1217-22-060
• Device Catalogue Number: 121722060
• Device Lot Number: BG4FC1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR