MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN MAR +4 10D 36IDX66OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	121936166
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.Occupation: attorney.
Event or Problem Description
Ppf alleges loosening of cup, dislocation and fracture of component.
Additional Manufacturer Narrative
This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.Product complaint #: (b)(4).Investigation summary: we received a ppf alleging loosening of cup, dislocation and fracture of component.Doi: (b)(6) 2008; dor: none reported; right hip.The patient is bilateral.Please see (b)(4) for the left hip.Note: the ppf does not specify to which hip the aes are related.The patient had a revision of the left hip.It is likely that the reported events are related to the left hip.The medical records report no allegations of loosening or fracture pertaining the right hip, and there was no revision reported.No device associated with this report was received for examination.There is no known allegation against this product code/lot number combinations.A complaint database search and/or device manufacturing (dhr) review will not be performed, as it is not possible to identify related reports or identify related issues within a dhr when there is no known product allegation or adverse patient issue identified.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: null.Device history batch: null.Device history review: null.
Additional Manufacturer Narrative
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.  after review of the legal records, there were no allegations or deficiency for the right hip and no revision.Thus, this report was created in error and it will be rejected.

• Brand Name: PINN MAR +4 10D 36IDX66OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8304331
• Report Number: 1818910-2019-83211
• Device Sequence Number: 1663633
• Product Code: LPH
• UDI-Device Identifier: 10603295014645
• UDI-Public: 10603295014645
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2019

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 Catalogue Number: 121936166
• Device Lot Number: AJ2FW1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 02/01/2019; 02/13/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 02/06/2019; 02/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other