MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX +4 10D 36IDX58OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1221-36-158
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994); No Code Available (3191)
Date of Event	04/10/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.(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
It was reported that i and d was performed due to hematoma.Head and liner was revised.Patient alleges pain, loss of function and general debilitation of quality of life, and emotional distress.Doi: (b)(6) 2015.Dor: (b)(6) 2015; 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.No device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction wi-7915 appendix a.For this investigation, no immediate action was required as no alleged deficiency with the device(s) was identified.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No product contribution to the reported event was identified and no information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
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.No device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction wi-7915 appendix a.For this investigation, no immediate action was required as no alleged deficiency with the device(s) was identified.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.- from the event information received, it was not possible to determine the relationship of the device to the reported event.No product contribution to the reported event was identified and no information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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.
Event or Problem Description
After review of medical records, patient was revised to address hematoma.Revision notes reported that by opening the previous incision which was healed, there was a large old hematoma that tracked from the skin through subcutaneous tissue and all the way down to hip joint.There was no evidence of purulent discharge or any tissue necrosis.
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.

• Brand Name: ALTRX +4 10D 36IDX58OD
• 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: 10540535
• Report Number: 1818910-2020-20181
• Device Sequence Number: 571337
• Product Code: LPH
• UDI-Device Identifier: 10603295016434
• UDI-Public: 10603295016434
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K072963
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/10/2015

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: 1221-36-158
• Device Catalogue Number: 122136158
• Device Lot Number: 242427
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2020
• Supplement Date Received by Manufacturer: 01/14/2021; 02/19/2021; 03/29/2021
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 01/15/2021; 03/02/2021; 03/30/2021
• 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: CORAIL2 NON COL HO SIZE 13; DELTA CER HEAD 12/14 36MM +8.5; PINNACLE SECTOR II CUP 58MM; UNKNOWN HIP ACETABULAR CUP; CORAIL2 NON COL HO SIZE 13; DELTA CER HEAD 12/14 36MM +8.5; UNKNOWN HIP ACETABULAR CUP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR