MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 HA ACET CUP 50MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-11-050
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/12/2020
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
Patient reported to surgeon with dislocated hip after a fall.Surgeon operated on patient finding poly liner has been damaged inside acetabular shell.The ceramic head was also damaged.The acetabular shell was removed for way of a new prosthesis also.Additional information received 1/4/21 reporting a disassociation of liner from cup had occurred.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : examination of the returned device found evidence to support disassociation of the liner from the cup while implanted.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: PINNACLE 100 HA ACET CUP 50MM
• 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: 11170082
• Report Number: 1818910-2021-01061
• Device Sequence Number: 3583030
• Product Code: LPH
• UDI-Device Identifier: 10603295009054
• UDI-Public: 10603295009054
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K031495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2021

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: 1217-11-050
• Device Catalogue Number: 121711050
• Device Lot Number: HG2307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2020
• Initial Date Received by Manufacturer: 01/04/2021
• Supplement Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 05/06/2021
• 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: DELTA CER HEAD 12/14 32MM +9; PINN MAR +4 10D 32IDX50OD; DELTA CER HEAD 12/14 32MM +9; PINN MAR +4 10D 32IDX50OD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR