MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 ACET CUP 48MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-01-048
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hematoma (1884); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
On (b)(6) 2019, the patient underwent a left hip revision due to mechanical complication of internal joint implant.The surgeon noted a hematoma, discoloration from metal abrasion, and the removal of scar tissue.The liner was worn and disassociated from the cup with minor contact of the head against the metal ring.The head and liner were exchanged.The cup and stem were retained.There were no indicated intra-operative complications.Doi: (b)(6) 2015, dor: (b)(6) 2019, left hip.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Investigation summary: no device associated with this report was received for examination.This device was manufactured on 17-nov-2014.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot: 1) quantity manufactured: 10.2) date of manufacture: 17-nov-2014.3) any anomalies or deviations identified in dhr: one nc (non-conformance) found associated with 8023154.Nc: 043435 was opened to introduce additional verification when running m/c op 2 first off on cmmq0049.This was a planned nc to allow start of the 2nd part in cnc after getting the taper diameter measured in the cmm on the 1st off.There is no correlation between nc: 043435 and the complaint failure mode.4) expiry date: 31-oct-2024.5) ifu reference: 090200701.

• Brand Name: PINNACLE 100 ACET CUP 48MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11649716
• Report Number: 1818910-2021-07667
• Device Sequence Number: 3367265
• Product Code: LPH
• UDI-Device Identifier: 10603295008538
• UDI-Public: 10603295008538
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

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: 1217-01-048
• Device Catalogue Number: 121701048
• Device Lot Number: 8023514
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 06/11/2021
• 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: APEX HOLE ELIM POSITIVE STOP.; CORAIL CEM STEM STD S11.; HIP BALL BIOLOX 32 +5 12/14.; PINN MAR +4 10D 32IDX48OD.; APEX HOLE ELIM POSITIVE STOP; CORAIL CEM STEM STD S11; HIP BALL BIOLOX 32 +5 12/14; PINN MAR +4 10D 32IDX48OD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR