MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 ACET CUP 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-01-052
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2021
Type of Reportable Event	Malfunction
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
Hcp sent an e-mail to sales rep: on (b)(6) 2021 surgeon had issues with the apex hole eliminator, lot d20091400.A thread-error occurred.The hole eliminator was scrapped by hospital and another apex he was used without issues.No surgical delay reported, no adverse patient and/or user consequence reported.
Additional Manufacturer Narrative
Product complaint # = > (b)(4) investigation summary = > no device associated with this report was received for examination.The device manufacturing records have been reviewed.No related deviations or anomalies identified.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 = > product 121701052 lot 9624259.Ten pieces manufactured november 03, 2020.All parts manufactured per specification and raw material met specifications.Device history review = > product 121701052 lot 9624259.Ten pieces manufactured november 03, 2020.All parts manufactured per specification and raw material met specifications.Corrected: a1.

• Brand Name: PINNACLE 100 ACET CUP 52MM
• 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: 11377726
• Report Number: 1818910-2021-03819
• Device Sequence Number: 19776699
• Product Code: LPH
• UDI-Device Identifier: 10603295008552
• UDI-Public: 10603295008552
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1217-01-052
• Device Catalogue Number: 121701052
• Device Lot Number: 9624259
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/02/2021
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 04/18/2021
• 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 36IDX52OD; APEX HOLE ELIM POSITIVE STOP; PINNACLE 100 ACET CUP 52MM; ALTRX NEUT 36IDX52OD; APEX HOLE ELIM POSITIVE STOP; PINNACLE 100 ACET CUP 52MM