MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 S-ROM*SLEEVE PRX ZTT, 16B-LRG; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

Catalog Number	521465
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Tissue Damage (2104); Osteolysis (2377); Inadequate Osseointegration (2646); Not Applicable (3189)
Date of Event	01/12/2010
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
The patient was revised because of pain and lysis.Doi: (b)(6) 2003 dor: (b)(6) 2010.Update 07/28/2011 - litigation papers received.There is no new additional information that would affect the investigation.Patient is a resident (b)(6).Update 11/18/2012 - patient's medical records were received from legal.The complaint has been reopened.There is no new information that would change the existing mdr decision.Additional medical records are available on the external hard drive if needed.Update ad 23 may 2018 (b)(4) is reopened under (b)(4)due to receipt of ppf and implant sticker sheet received.In addition to what was previously reported, ppf alleges loosening of the cup and stem, bone and implant fracture, metal wear and metallosis, and elevated metal ions.The lawyer and firm has been updated.The cup, head, stem, and sleeve has been added in ip's.Doi: (b)(6) 2003; dor: (b)(6) 2010; left hip.
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
Ppf and implant sticker sheet received.In addition to what were previously reported, ppf alleges loosening of the cup and stem, bone and implant fracture, metal wear, metallosis, and elevated metal ions.An unknown hip implant was added due to alleged component fracture since it is not known which implant fractured.The stem, cup and sleeve were added as well.Doi: (b)(6)2003; dor: (b)(6)2010; left 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7624568
• Report Number: 1818910-2018-62793
• Device Sequence Number: 16618791
• Product Code: LPH
• UDI-Device Identifier: 10603295170624
• UDI-Public: 10603295170624
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K934412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2018

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: 521465
• Device Lot Number: 1029854
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2018
• Supplement Date Received by Manufacturer: 05/23/2018; 08/16/2018
• Initial Report FDA Received Date: 06/21/2018
• Supplement Report FDA Received Date: 06/21/2018; 09/04/2018
• 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: 34 YR
• Patient Weight: 104