MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR +4 10D 36IDX62OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1219-36-162
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/29/2019
Type of Reportable Event	Serious Injury
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
Patient underwent primary thr on (b)(6) 2019 where a corail pinnacle was implanted.As per the notes, the patient dislocated 2 times and was then brought back to theatre on (b)(6) 2019 where the pinnacle liner was exchanged to a constrained liner and a longer femoral head implanted.Patient has now presented with pain with a the x ray showing the hip to be dislocated.According to the patient, his hip has never been right and he has suffered with pain since the original index surgery.The x ray images show a dislocated hip, locking ring around the neck and the ring that locks the poly into the shell, broken and lying in the surrounding soft tissue.On opening the hip, backend soft tissue was evident, the poly locking ring was located, bent and broken and the poly liner was found exerted in the soft tissue and not in the shell.The blackened tissue was removed, the liner removed.A new constrained liner was implanted and a head without a ¿skirt¿ implanted (the previous head ad a skirt and would have resulted in more impingement) only the products removed in this surgery have been listed.This complaint was created to capture the previous revision on (b)(6) 2019 due to dislocation.This is related to (b)(4) which captures the second revision on (b)(6) 2022 due to dislocation.Doi: (b)(6) 2019.Dor: (b)(6) 2019.Right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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 : 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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: PINN MAR +4 10D 36IDX62OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14461229
• Report Number: 1818910-2022-09291
• Device Sequence Number: 4722490
• Product Code: LPH
• UDI-Device Identifier: 10603295014621
• UDI-Public: 10603295014621
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K010171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• 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
• Report Date (Section B): 05/20/2022

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: 1219-36-162
• Device Catalogue Number: 121936162
• Device Lot Number: H24896
• 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: 05/04/2022
• Supplement Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2016
• 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: ARTICULEZE M HEAD 36MM +8.5; CORAIL AMT COLLAR SIZE 18; PINN MAR +4 10D 36IDX62OD; PINN SECTOR W/GRIPTION 62MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male