MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE PRX ZTT, 16B-SML; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

Model Number	52-1463
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Discomfort (2330); Ambulation or Postural Difficulties (2544); Limb Fracture (4518); Physical Asymmetry (4573); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/30/2019
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
(b)(4).Litigation papers allege pain and discomfort in her left hip causing potential unnecessary and additional surgeries, diminution in earning capacity, lost wages, medical monitoring expenses, emotional distress, loss of enjoyment of life, metallosis exposure and other injuries presently undiagnosed.Further alleged the patient was injured by excessive levels of chromium and cobalt.Doi: (b)(6) 2008 - dor: none reported (left hip) patient is resident of (b)(6).Update: 12/6/2011 plaintiff's preliminary disclosure (ppd) form received (b)(6) 2011.There was no new information received that would impact the outcome of the investigation.Update ad 19 jun 2019: (b)(4) has been re-opened under (b)(4) due asr plaintiff disclosure form records received.Pdf indicated that the patient had underwent revision surgery.Reported revision date.Doi: (b)(6) 2008.Dor: (b)(6) 2019.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.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.H6 clinical code: appropriate term / code not available (e2402) is used to capture blood heavy metal increased.

• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12518571
• Report Number: 1818910-2021-20870
• Device Sequence Number: 14745974
• Product Code: LPH
• UDI-Device Identifier: 10603295170617
• UDI-Public: 10603295170617
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2010
• Device Model Number: 52-1463
• Device Catalogue Number: 521463
• Device Lot Number: 1980729
• 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: 09/14/2021
• Supplement Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 11/25/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2005
• 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: ADAPTER SLEEVE 11/13 +6; ASR ACETABULAR CUPS 50; ASR UNI FEMORAL IMPL SIZE 45; SROM STM ST,36+6L NK,11X16X150
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female