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 Codes	Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/01/2020
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
Surgeon is reporting a revision of an unknown pinnacle inlay unknown side because of fracture of inlay a surgical delay was not reported.Doi: (b)(6) 2017.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: following review of the information received, it was concluded that it was unlikely that a potential product issue was present.The complaint shall be entered onto the complaints database and monitored through trend analysis.Should further information be received, then the complaint shall be reviewed and further investigation completed as required.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: following review of the information received, it was concluded that it was unlikely that a potential product issue was present.The complaint shall be entered onto the complaints database and monitored through trend analysis.Should further information be received, then the complaint shall be reviewed and further investigation completed as required.Device history lot : product code 121701048, work order (b)(4) was manufactured on 19/july/2017.¿ (b)(4) parts were manufactured per specification and all raw materials met specification.¿ no scrap parts associated with this lot.¿ no reprocessing associated with this lot.¿ expiry date of the lot is 30/june/2027.¿ ifu number: 090200701.¿ no deviations found.

• 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: 10232868
• Report Number: 1818910-2020-14977
• Device Sequence Number: 547939
• Product Code: LPH
• UDI-Device Identifier: 10603295008538
• UDI-Public: 10603295008538
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K000306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• 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,Followup
• Report Date (Section B): 06/24/2020

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: 8586808
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 07/15/2020; 06/16/2021
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 07/15/2020; 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: APEX HOLE ELIM POSITIVE STOP; CORAIL2 STD SIZE 10; DELTA CER HEAD 12/14 32MM +5; PINN MAR +4 10D 32IDX48OD; PINNACLE 100 ACET CUP 48MM; APEX HOLE ELIM POSITIVE STOP; CORAIL2 STD SIZE 10; DELTA CER HEAD 12/14 32MM +5; PINN MAR +4 10D 32IDX48OD; PINNACLE 100 ACET CUP 48MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 96