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	09/08/2021
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
Intraoperatively the hole eliminator did not stop in the cup´s hole as it should.It was possible to screw the hole eliminator too deep.It now shows up prominent at the cup´s dome in x-ray.Unknown side, initial surgery.No surgical delay reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.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 code 121701052, finish good work order (b)(4) was manufactured on 10-nov-2020.8 parts were manufactured per specification and all raw materials met specification.Scrap: 2 parts from this lot were scrapped at the unload clean & passivate process step, for scrap reason code a603: ¿step od (outer diameter) visual¿.The outer diameter for all parts processed at the unload clean & passivate process step are 100% visually inspected as per tm-101192 rev 4 (test method for the pinnacle cleanline and passivate steps.) all scrap parts were removed from lot 9588496 as per scp-csop0619 scrap procedure, therefore there is no correlation with the complaint failure mode.Reprocessing: there was no material reprocessing reports (mrr) associated with this lot.Non-conformance: there were no non-conformances associated with this lot.This lot is not part of field action bounding for capa-010284.Expiry date: 31-october-2030.Ifu reference: (b)(4).Product code 121701052p, issued foundry casting work order (b)(4) was manufactured on 20-aug-2020.10 parts were manufactured per specification and all raw materials met specification.Scrap: there was no scrap associated with this lot.Reprocessing: there was no material reprocessing reports (mrr) associated with this lot.Non-conformance: there were no non-conformances associated with this lot.Product code 121701052p, issued foundry casting work order (b)(4) was manufactured on 20-aug-2020.10 parts were manufactured per specification and all raw materials met specification.Scrap: there was no scrap associated with this lot.Reprocessing: there was no material reprocessing reports (mrr) associated with this lot.Non-conformance: there were no non-conformances associated with this lot.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary : no device associated with this report was received for examination.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.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 code 121701052, finish good work order (b)(4) was manufactured on 10-nov-2020.(b)(4) parts were manufactured per specification and all raw materials met specification.Scrap: 2 parts from this lot were scrapped at the unload clean & passivate process step, for scrap reason code a603: ¿step od (outer diameter) visual¿.The outer diameter for all parts processed at the unload clean & passivate process step are 100% visually inspected as per tm-101192 rev 4 (test method for the pinnacle cleanline and passivate steps.) all scrap parts were removed from lot 9588496 as per scp-csop0619 scrap procedure, therefore there is no correlation with the complaint failure mode.Reprocessing: there was no material reprocessing reports (mrr) associated with this lot.Non-conformance: there were no non-conformances associated with this lot.This lot is not part of field action bounding for capa-010284.Expiry date: 31-october-2030.Ifu reference: 090200701.Product code 121701052p, issued foundry casting work order (b)(4) was manufactured on 20-aug-2020.(b)(4) parts were manufactured per specification and all raw materials met specification.Scrap: there was no scrap associated with this lot.Reprocessing: there was no material reprocessing reports (mrr) associated with this lot.Non-conformance: there were no non-conformances associated with this lot.Product code 121701052p, issued foundry casting work order (b)(4) was manufactured on 20-aug-2020.(b)(4) parts were manufactured per specification and all raw materials met specification.Scrap: there was no scrap associated with this lot.Reprocessing: there was no material reprocessing reports (mrr) associated with this lot.Non-conformance: there were no non-conformances associated with this lot.

• 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
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12605144
• Report Number: 1818910-2021-22506
• Device Sequence Number: 1415209
• 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
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2021

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: 9588496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2021
• Supplement Date Received by Manufacturer: 11/30/2021; 12/17/2021
• Initial Report FDA Received Date: 10/11/2021
• Supplement Report FDA Received Date: 11/30/2021; 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACTIS COLLARED HIGH SIZE 3; ALTRX NEUT 32IDX52OD; APEX HOLE ELIM POSITIVE STOP; DELTA CER HEAD 12/14 32MM +5; PINNACLE 100 ACET CUP 52MM
• Patient Age: 63 YR
• Patient Sex: Female