MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR NEUT 32IDX58OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1219-32-058
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374); Ambulation or Postural Difficulties (2544); Joint Laxity (4526)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
T was reported that "the purpose of this letter is to request information about your equipment that is reported to have been used in a total hip arthroplasty (tha) in (b)(6) 2005.The next 15 years the hip prosthesis worked well, however, in 2020, pain with trouble walking became my life.At present time there is approximately 1.55mm superior migration of the femoral head.The information that is requested is: what type of polyethylene was used, what is the long term wear evaluation, and when is a revision suggested.".
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter is the patient.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
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 synthese joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthese joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Patient called back with apologies for missing the first 3 attempts.He states he has pain in his buttocks that radiates down his leg.His surgeon has notified him that this is likely due to an issue in his back.He also feels like his hip is "popping out of place" but it corrects itself without further intervention.His primary surgery was done in (b)(6) of 2005.He is agreeable to the authorization forms.Authorization forms have been mailed to him on (b)(6) 2022.
Event or Problem Description
Additional information received was reviewed and stated that the patient had his primary surgery on (b)(6) 2005 and provides sticker sheets from the primary surgery.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post-market surveillance, or other events within the quality system.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.H10 additional narrative: added: d4 (lot, expiration date, udi), h4, g4 (pma), d10 corrected: b5, d1, d2a, d2b, d4 (product code), d6a, h6 (clinical code).

• Brand Name: PINN MAR NEUT 32IDX58OD
• 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15212077
• Report Number: 1818910-2022-15644
• Device Sequence Number: 4581879
• Product Code: LPH
• UDI-Device Identifier: 10603295013938
• UDI-Public: 10603295013938
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/11/2022

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 Expiration Date: 09/15/2010
• Device Model Number: 1219-32-058
• Device Catalogue Number: 121932058
• Device Lot Number: Z2BCL1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2022
• Supplement Date Received by Manufacturer: 08/11/2022; 09/08/2022; 12/08/2022
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 08/17/2022; 09/08/2022; 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2020
• 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: ARTICUL/EZE BALL 32 +9 BL; PINN MAR NEUT 32IDX58OD; PINNACLE 100 ACET CUP 58MM; SUMMIT POR TAPER SZ6 HI OFF; UNKNOWN HIP FEMORAL HEAD
• Patient Age: 79 YR
• Patient Sex: Unknown