MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN MAR LIP LNR 32IDX56OD; HIP ACETABULAR INSERT/LINER

Catalog Number	121932256
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Neck of the prostheses is broken 9 years after implantation.Luxation of the hip.Neck fracture of the prostheses.Revision is planned on monday (b)(6) 2016.2007 first surgery after 4 years change from ceramic liner to poly liner.Update 27 jul 2017: email notification from steve backhouse received.There is no new information added.This complaint was update on: aug 15, 2017.Update aug 15, 2017: additional information received.Updated the cup product.There is no new information added that changes the mdr decision.This complaint was updated on: aug 18, 2017.
Additional Manufacturer Narrative
No device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
(b)(4).Investigation summary: the complaint was reopened in unity due to additional information received stating that the complaint was due to implant fracture of the stem this was already noted in the previous complaint which can be referenced for further details.No further actions identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINN MAR LIP LNR 32IDX56OD
• Common Device Name: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6864771
• Report Number: 1818910-2017-24589
• Device Sequence Number: 18997581
• Product Code: LPH
• UDI-Device Identifier: 10603295014201
• UDI-Public: 10603295014201
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K000306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/15/2017

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: 12/01/2016
• Device Catalogue Number: 121932256
• Device Lot Number: E84KP1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Initial Date Received by Manufacturer: 08/15/2017
• Supplement Date Received by Manufacturer: 11/21/2017; 01/12/2018; 02/06/2018; 02/22/2018; 03/07/2018
• Initial Report FDA Received Date: 09/14/2017
• Supplement Report FDA Received Date: 11/22/2017; 01/17/2018; 02/09/2018; 02/26/2018; 03/14/2018
• 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: Required Intervention
• Patient Age: 43 YR
• Patient Weight: 57