MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MODULAR DUAL MOBILITY INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU

Catalog Number	626-00-48G
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Edema (1820); Pain (1994); Injury (2348)
Date of Event	06/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device evaluated by mfr: device not available.
Event or Problem Description
It was reported that the patient's left hip was revised.Patient presented with complaint of pain (location and severity of pain unknown), subsequent scans revealed the presence of pseudo tumor.Intra-operatively, no black tissue noted but the patient did have discolored fluid.The shell, mdm/ adm liner construct, and biolox ceramic head were revised to a competitor shell and liner with a stryker c-taper head.The stem was not revised.The explants are available for return.
Additional Manufacturer Narrative
Reported event an event regarding altr and discolored fluid involving a mdm liner was reported.The event was not confirmed.Method & results -product evaluation and results: visual inspection was performed as part of the material analysis report mar, dated (b)(6) 2019.It was noticed that in the mar report the "adm insert" refers to the mdm liner and the "x3 liner" refers to the "adm liner".Nothing noteworthy was observed on the returned mdm insert.Material analysis of the returned device noted the following: x-ray fluorescence spectroscopy xrf analysis was performed on the mdm liner to determine material composition.The mdm material is consistent with astm f1537 co-cr-mo per drawing.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-medical records received and evaluation: no medical records were received for review with a clinical consultant.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the mar report indicated that based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's left hip was revised.Patient presented with complaint of pain (location and severity of pain unknown), subsequent scans revealed the presence of pseudo tumor.Intra-operatively, no black tissue noted but the patient did have discolored fluid.The shell, mdm/ adm liner construct, and biolox ceramic head were revised to a competitor shell and liner with a stryker c-taper head.The stem was not revised.The explants are available for return.

• Brand Name: MODULAR DUAL MOBILITY INSERT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8803228
• Report Number: 0002249697-2019-02593
• Device Sequence Number: 16225099
• Product Code: LZO
• UDI-Device Identifier: 04546540666031
• UDI-Public: 04546540666031
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K103233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2019

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 Expiration Date: 04/30/2021
• Device Catalogue Number: 626-00-48G
• Device Lot Number: 55241402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Initial Date Received by Manufacturer: 06/21/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 09/23/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 62 YR