MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR NEUT 28IDX48OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1219-28-048
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/21/2021
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 was suffering from hip pain in her replaced hip.Initial surgery was done in (b)(6) 2006.Femoral head and poly swap was performed.Dr.Fox believes the liner was possibly dislodged from the cup at one point due to a possibly damaged ard.There was noticeable polyethylene wear.On the explanted liner.Doi: (b)(6) 2006, dor: (b)(6) 2021, unknown hip.
Event or Problem Description
Additional information was received indicated that the surgeon thought the liner was disassociated at one time.It was not at the time of surgery.There was no fracture in the liner.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5 and d10 (concomitant product: unknown hip acetabular cup).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h6 (removed device code: fracture).
Event or Problem Description
Questions; a.Can you please confirm if there was disassociated occured between the head and liner (liner was possibly dislodged at one point).B.Kindly confirm if there was a fracture on the liner (possibly damaged ard).C.Was there surgical delay during revision? if yes, please provide the duration.D.Please indicate the affected side.E.Kindly provide patient name or initials.Response: - the surgeon thought the liner was disassociated at one time.It was not at the time of surgery.There was no fracture in the liner.Unfortunately i do not have any further information.
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 material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.H10 additional narrative:  added: b5 corrected: h6 (device).Removed pec fractured liner poly.

• Brand Name: PINN MAR NEUT 28IDX48OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11778452
• Report Number: 1818910-2021-09599
• Device Sequence Number: 3894324
• Product Code: LPH
• UDI-Device Identifier: 10603295013280
• UDI-Public: 10603295013280
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2021

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: 1219-28-048
• Device Catalogue Number: 121928048
• Device Lot Number: AS3A91000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 05/14/2021; 06/02/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 05/27/2021; 06/03/2021
• 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: PINN MAR NEUT 28IDX48OD; S-ROM*HEAD FEMORAL COCR 28+0
• Outcome Attributed to Adverse Event: Required Intervention