MAUDE Adverse Event Report: ZIMMER GMBH FITMORE, HIP STEM, UNCEMENTED, B/5, TAPER 12/14; ZIMMER POROLOCK MIS STEM

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	01/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: item#00-8755-054-00, lot# 2624350, allofit it alloclassic, shell for acetabulum, uncemented, 54/jj; item#00-8775-011-32, lot# 2618606, biolox delta ceramic taper liner, size jj / 32 i.D.For use with 54 mm o.D.Size jj shell; item#00-8775-032-02, lot# 2615148, biolox delta, ceramic femoral head, m, 32/0,taper 12/14; item# 01.00551.205, lot# 2591179, fitmore, hip stem, uncemented, b/5, taper 12/14.The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Study report was received and will be reviewed as part of ongoing investigation.Device history record (dhr) was reviewed and no discrepancies were found.The following report is associated with this event: 0009613350-2019-00227.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
It was reported the patient was experiencing moderate to severe pain and some problems ambulating approximately 7 years post implantation.The patient has taken pain medication weekly.Attempts to obtain additional information have been made and no further information has been provided.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of initial medwatch.New information received: health care facility information received.Corrected and additional information is filled in the follwing fields: the following report is associated with this event: 0009613350-2019-00227.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
Please refer to report 0009613350-2019-00226.
Additional Manufacturer Narrative
This follow-up report is being filled to relay investigation result.Dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trigger considering the following event is identified: pain / difficulty in ambulating event description: patient underwent a right total hip arthroplasty on (b)(6) 2012 and subsequently experienced moderate to severe pain and problems related to movement.Review of received data: - operation notes dated (b)(6) 2012 is reviewed.No abnormality is observed.- crf report is reviewed.Leg length discrepancy of 1cm is noted beginning on (b)(6) 2013 and decreased to 0.5cm in the upcoming visits.Cup inclination was 40 post-op and noted to be 35 beginning on jan 12, 2015, however, on the last visit it was measured 40 again.Patient has some problems with mobility and usual activities.No problems with self-care.Extreme pain in eq5d ¿ 0.088.Moderate pain and no limp and no deformity noted in harris hip.Cup inclination is 40 degrees, 10 degrees of anteversion.No cup migration.No radiolucency.Stem position is neutral.No stem shift or subsidence.No radiolucency.No heterotropic ossification.Device analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: all involved devices are intended for treatment.The compatibility check was performed from and showed that the product combination was approved by zimmer biomet.Conclusion: the quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.2 ncrs were found for the allofit shells which ended up 2 items being scrapped.The investigation results did not identify a non-conformance or a complaint out of box (coob).Pain cannot be related to a single specific failure mode.Based on the given information, a root cause analysis is therefore not possible.Should any additional information that changes the assessment become available, the case will re-evaluated.Based on the given information the complaint could not be confirmed.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: FITMORE, HIP STEM, UNCEMENTED, B/5, TAPER 12/14
• Common Device Name: ZIMMER POROLOCK MIS STEM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8518478
• Report Number: 0009613350-2019-00226
• Device Sequence Number: 13913150
• Product Code: KWA
• UDI-Device Identifier: 00889024483118
• UDI-Public: 00889024483118
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: foreign,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/25/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 01.00551.205
• Device Lot Number: 2591179
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/23/2019
• Supplement Date Received by Manufacturer: 04/24/2019; 07/02/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 04/24/2019; 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Weight: 110