MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX NEUT 32IDX54OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1221-32-054
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/27/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that the poly disassociated from the cup.Inserted a new poly with no issues with locking mechanism.Poly was locked and stable.Doi: (b)(6) 2010.Dor: (b0(6) 2021.Right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Examination of the provided x-ray images does find sufficient evidence to confirm the reported disassociation event.The position of the femoral head appears in direct contact with the inner surface of the acetabular cup which is indicative of the liner having disassociated.A root cause cannot however be determined using the two provided images.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: ALTRX NEUT 32IDX54OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11805370
• Report Number: 1818910-2021-09970
• Device Sequence Number: 3481614
• Product Code: LPH
• UDI-Device Identifier: 10603295016120
• UDI-Public: 10603295016120
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K072963
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1221-32-054
• Device Catalogue Number: 122132054
• Device Lot Number: EC3A51000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 06/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALTRX NEUT 32IDX54OD; APEX HOLE ELIM POSITIVE STOP; ARTICUL/EZE BALL 32 +5 BR; CORAIL2 STD SIZE 12; PINNACLE 300 ACET CUP 54MM; ALTRX NEUT 32IDX54OD; APEX HOLE ELIM POSITIVE STOP; ARTICUL/EZE BALL 32 +5 BR; CORAIL2 STD SIZE 12; PINNACLE 300 ACET CUP 54MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR